FDA Papers, November 1971 - quackwatch.org · PAPERS VOL. 5, NO. 9/NOVEMBER 1971 New Directions in Import Coverage New techniques and expansion 4 in imports caii for new methods to

NOVEMBER 1971

"We are carefully to preserve that life which the Author of

nature has given us, for it was no idle gift."

The incidents in 1971 involving botulinum toxinin commercialy processed foods, although regret

table, have brought to public attention once again how extremely potent is this foodborne poison and how a single instance of carelessness, accident, or error in canning and some other food preservation techniques can result in tragedy.

Because Americans depend more and more on foods that are commercially processed and ready to eat, it is fortunate that the food processing industries for many years have been well aware of the potential dangers of botulism and have developed safe methods of processing that when properly followed reduce the possibility of botulinum food poisoning from commercial products practically to zero.

But many householders still preserve some of their own foods and some of them fail to follow recommended canning and other preservation procedures that have been found to assure protection against botulism and other food poisoning or infections. Thus, most outbreaks of botulism are still caused by foods improperly preserved in the home.

Although neither FDA nor any Government organization can be responsible for how a householder preserves foods for his own use, this Agency believes that those who prepare or process foods-in industry and the home-should know more about botulism in general and the precautions that should be taken to avoid botulinum poisoning. The article in this issue (see page 16) is aimed toward that end.

Harvey W. Wiley, 1844-1930

Father of the Federal Food and Drugs Act of 1906

From his commencement address "Life and the Coming Time"

Hanover College, 1867

FDA Papers I November 1971 I I

quotes

One step being taken is the shift of emphasisin inspection from production to management of production, which is to say quality control. This is a way of apportioning the effortinvested by FDA to supplement rather than duplicate the control being exercised by the industry.This is what we are terming Cooperative QualityAssurance. Where inspection shows the plant tohave good quality control, that plant can be encouraged to come into the self-certification program, which substitutes paperwork for much ofthe physical and end-product inspection. Wheredeficiencies in quality control are identified, thesecan be given emphasis in further surveillance,with other factors diminished in emphasis."

Virgil O. Wodicka, Ph.D., director. Bureau of Foods,for delivery to the National Association of MargarineManufacturers, New Orleans, December 3, 1971.

On November 12, 1971, we published in theFederal Register a proposal of the NationalCaimers Association for the issuance of a Statementof Policy. A series of specific requirements areproposed. These would facilitate the prompt application, when necessary, of the emergency permit provisions of Section 404 of the Federal Food,Drug, and Cosmetic Act. Commercially processedfoods for human consumption would be covered.Under this far-reaching proposal, all food cannerswould be subject to registration with the Foodand Drug Administration. The appendix attachedto the National Canners Association's proposedStatement of Policy actually sets forth detailedCurrent Good Manufacturing Practices for thecanning of foods. We have allowed 60 days forcomment on NCA's proposal."

Charles C. Edwards, M.D., Commissioner of Food andDrugs, for delivery to the 15th annual Joint EducationalConference, Food and Drug Law Institute-Food andDrug Administration, Washington, December 7, 1971.

E l l i o t U R i c h a r d s o nSecretary, U.S. Department ofH e a l t h . E d u c a t i o n , a n d W e l f a r e

Roger O. Egeberg, M.D.Asst. Secretary for Healtha n d S c i e n t i fi c A f f a i r s

Charles C. Edwards, M.D.Commissioner of Food and Drugs

J o h n T . W a l d e nDeputy Asst. Commissionerf o r P u b l i c A f f a i r s

Harold C. Hopkins/Editor ial Director

J e s s e R . N i c h o l s / A r t D i r e c t o r

Dan O'Too le /Photographer

Joan M. Galloway/Managing Editor

Frederick L. Townshend/Product ion Mgr.

PHOTOGRAPHY: Fred Ward--Black Star, insidefront cover, 21. 22. upper and lower left 23. topand m idd le l e f t 24 ; FDA.

FDA PAPERS, the official magazine of the Foodand Drug Administration, is published monthly,except for combined July-August and December-January issues. Subscriptions may be orderedfrom the Superintendent of Documents.Government Printing Office. Washington. D.C. 20402,at $3.50 a year ($1.00 additionai for foreign maiiing).

Address for editorial matters: FDA PAPERS,CE-20, Food and Drug Administration,5600 Fishers Lane, Rockviile, Md. 20852.

Articies pubiished in FDA PAPERS are in thepublic domain and text may be republishedwithout permission. Use of funds for printing thispubiication approved by Director of the Bureauof the Budget August 15. 1966.

Section 705 [375] of the Food, Drug, andC o s m e t i c A c t .

(a) The Secretary shaii cause to be publishedfrom time to time reports summarizing ailjudgments, decrees, and court orders which havebeen rendered under this Act. inciuding the natureof the charge and the disposition thereof.

(b) The Secretary may also cause to be disseminatedinformation regarding food, drugs, devices, orcosmetics in situations invoiving. in the opinionof the Secretary, imminent danger to health, orgross deception of the consumer. Nothing in thissection shaii be construed to prohibit the Secretaryfrom coiiecting. reporting, and ii lustrating theresuits of the investigations of the Department.

A d v i s o r s t o t h e E d i t o r *

H. Nelson Fitton, Department of Agriculture;George Creel, Department of Housing andUrban Development; William J. Cotter, PostOffice Department; Henry Scharer, Departmentof Commerce; Dr. Milner B. Schaefer,Department of the Interior; Dr. Sam Kaim,Veterans Administration; Dr. Peter V. Siegel,Federai Aviation Agency; Dr. Spofford G.English, United States Atomic EnergyCommission; Dr. Harve J. Carlson, NationalScience Foundation; Howard J. Lewis,National Academy of Sciences; Arthur Settel,B u r e a u o f C u s t o m s .

'The Food and Drug Administration is soleiyr e s p o n s i b i e f o r t h e c o n t e n t s o f F D A PA P E R S . T h eA d v i s o r s t o t h e E d i t o r a r e c o n s u l t a n t s o n m a t t e r srelating to the functions of the Federai Departmentsa n d A g e n c i e s i i s t e d .

2 / November 1971 / FDA Papers

P A P E R SVOL. 5, NO. 9/NOVEMBER 1971

New Directions in Import Coverage New techniques and expansion 4in imports caii for new methods to protect the consumer.

The Veterinarian and Drug Experience Reporting Encouraging 9veterinarians to report on unusual or adverse effects of anirrta! drugs.

Proving the Safety of Food Additives The probiems of conducting 13tests and assessing scientific data needed to assure safety

of food addi t ives.

Botulism Some facts about how this deadly poison is produced in 16some preserved foods and how we can protect ourselves from it.

Field Reports 25

Product Safety Report 29

News Highlights 32

S t a t e A c t i o n s 3 4

Seizures and Postal Service Cases 30

Notices of Judgment 38

FDA Papers / November 1971 / 3

New Directions In Import Coverageby Richard Klug

Imported products have increased in dollar volume by65 percent within the past ten vears. They currentlyrepresent 12.5 percent of the $200 billion total spentby the American consumer on products whose processing or distribution or both are subject to regulation bythe Food and Drug Administration.

Changes also have occurred in foreign trade andshipping. For example, imports formerly consisted inlarge part of raw materials that received further processing at a plant in the United States and subsequent inspection by FDA. Today imports consist more andmore of ready-to-buy consumer products that receive nofurther processing. With some exceptions involvingspecific drugs, FDA does not inspect foreign firms as itdoes domestic ones and therefore the coverage or inspection of imports is restricted to the product itself.

Increased use of air freight and containerization hasgreatly increased the flow of imports through our entryports. Containerization is the practice of shipping cargoin large, rugged, standardized size and shape boxes orvans from the exporting manufacturer's plant directly tothe city of final destination in the importing country.

In January 1971 FDA's Office of the Executive Director of Regional Operations (EDRO) began developing a new program for coverage of imported products.EDRO directs and manages the operations of FDA'sregional offices. These regional office operations aredesigned to obtain compliance with laws and regulations enforced by FDA through appropriate educationalor enforcement activities. These include inspections andinvestigations, collection and analysis of samples, andthe initiation of appropriate enforcement actions. Coverage of imported products is included in these operations.

The EDRO field import coverage strategy developedearly in the calendar year 1971 drastically alters and insome cases abandons traditional operating proceduresto cope with the increasing import traffic and changes inforeign commerce and shipping technology. The newdirection consists of three major groups of activities:Administrative and procedural, state-side, and overseas.Two of the more important individual programs includethe Ship-to-Ship method of imports coverage tested byNew Yo rk D i s t r i c t ' s I n t e rna t i ona l Sec t i on and t he"Circuit Rider" program tested by Dallas District.

Administrative and Procedural Activities. The estab

lishment of an import operations coordination office inEDRO is complete. This office will provide uniformityof import procedural operations, coverage, and enforcement; a central point for rapid dissemination of information; more efficient and proper use of resources; co-ordination of import activities with the Bureaus forprogram guidance; and management of the implementation and operation of the strategy.

The possible use of a new standardized reportingform (Report of Import Entry—RIE) is being considered. The new form, in addition to providing FDAwith complete notification of entries of products it regulates, would replace four official forms, numerous unofficial forms, rubber stamps, and some other materialsnow in use; this form would save considerable time inthe collection of import samples annually, would be acomplete daily workload source, and would become adata resource document.

The possible development of a new FDA import datareporting system (data bank) is also under consideration for future use. This system, using the RIE, wouldidentify FDA's total import workload as to commodity,problem, volume, country of origin, importer, and district. It would also be used to record accomplishmentand enforcement data.

Stateside Activities. The use of mobile laboratoriesfor import coverage is being and will continue to betested. It is anticipated that mobile laboratories willgreatly expand FDA's coverage. A weakness of thetraditional program is the inability of laboratories tohandle the number of analyses of import samples generated by the inspection staffs. The use of small, maneu-verable, mobile laboratories, operated by inspectors andinspector technicians who have been trained to performsanitation and economic examinations, may help tosolve this problem. Through this approach the sanitationand economic samples collected annually can be examined right on the pier with no additional inspectormanpower. In addition the analyst would be freed touse his talents more efficiently on complicated methods.

Ship-to-ship coverage of imports has been understudy in a pilot test and preliminary results are promising. This involves actual field examination of moreimported products instead of the mere review of entrydocuments to determine what lots are to be sampled.


Ship-to-Ship Coverageby Frank Bruno

Although the idea of ship-to-ship coverage of importsis not new at FDA, it was never tested as a total conceptuntil April 1971 when a pilot study was undertaken in alimited area of the port of New York. The objective wasto determine if the scope of import coverage could beexpanded to keep pace with the changing modes ofcargo transportation without expanding the availablem a n p o w e r r e s o u r c e s .

Under the traditional method, import commoditiesare covered by the preselection of consignments on thebasis of review of U.S. Customs entry documents. Thissometimes resulted in inspectional and analytical manpower being allocated to nonviolative products whileunobserved, noncomplying consignments entered foodchannels through a "release without examination*' act i o n .

With the ship-to-ship method, the import inspector isplaced at the point of discharge, a pier, airport, orcontainer terminal, so he may inspect, examine, and/orsample cargo as it is discharged from its carrier. Hisdeterminations as to which import products require hisattention for adulteration or misbranding are made fromactual visual observations instead of review of documents that merely identify the importation and itsownership. Thus, a wider range of suspect imports comeunder his scrutiny for possible violations. This methodrequires the inspector to perform basic examinations inthe field for all commodities suitable for field testing. Itobviates the need for sampling of many commoditiesfor laboratory examination and thereby frees the analyststo perform the more complicated analyses with theirmore sophisticated instrumentation. Stationing the inspector at the point of discharge where he can view theactual commodities places him in an advantageous position to detect cargo that has undergone physical damageor adulteration from polluted harbor water or spillage oftox ic chemica ls .

Aiding this new technique, modestly equipped mobilelaboratories are used by the inspectors to increase theirfield examination capabilities and provide atmosphereand environment conducive to conclusive on-the-spotfield examinations.

Ship-to-ship coverage is one way to keep in step withthe modern trend toward rapid and uninterrupted movement of import cargo from origin to destination. The on-the-spot coverage it provides for many commodities is aboon to the importer, who demands the fastest possibledelivery of his import shipment. Conclusive field analysisby the inspector expedites the clearance of those consignments that are in compliance and reduces the probability that the importer will have to pay needlessdemurrage charges.

The ship-to-ship pilot test by New York District hasproved most gratifying. Coverage of imports increasedover 200 percent as compared to the traditional methodof operation. During the three-month test approximately

3,000 actions were completed as compared to thenortnal average of 900 actions.

The use of an import "Circuit Rider" program is nowunder study. It will extend our coverage to the remoteports not previously covered regularly. This programwill also expand our information about these outlyingentry ports. Regular but not prescheduled visits to theseremote ports will permit FDA to improve local FDA/U.S. Customs relations, check products entering theseports, and advise Customs officials of current prioritiesand problems.

^Circuit Rider' Coverageby Raymond V. Mlecko

Dallas District initiated the circuit rider imports coverage program in the Laredo District of the U.S. Bureauof Customs on August 9, 1971. Laredo District extendsalong a 390-mile stretch of the Texas-Mexico borderand contains eight ports that process import entries thatare subject to the laws enforced by the Food and DrugAdministration. Each port specializes more or less indifferent commodities. For example, the port of Brownsville handles more than 2,800 entries of shrimp andfish products a year; the port of Hidalgo annually processes more than 6,200 entries of fresh fruits and vegetables; the port of Laredo is the main entry point forfrozen strawberries.

During the week of August 9, FDA imports inspectorsvisited five of these ports. A specific FDA/Customsagreement was subsequently worked out at each port asto the method by which Dallas District will be notifiedof entries, types of entries from which Customs will takesamples, and other elements. The agreements are specificfor each port and the details will depend on such facts asthe commodities entered and past relationships withC u s t o m s .

Based on our initial visit with Customs, these pointsbecame apparent:

• Most of the port directors and their staffs werepleased that FDA is now taking a more active role inregulating entries through their area.

• Customs officials at each port were aware thatcertain importers are making informal entries of foodstuffs and then consolidating the merchandise on theU.S. side for subsequent shipment. They stated that theycan require formal entries to be filed in these cases ifthey know that the merchandise is suspect.

• Laredo District has experienced a marked increasein food imports in recent years and a continuing increaseis anticipated.

During the past seven weeks our circuit rider program has been operational, the immediate results havebeen gratifying. Some of these:

^ At the port of Laredo, small informal entr ies of

pottery (under $250 value) had entered the UnitedStates. However, Customs is now requiring that formalentries be filed for certain types of pottery shipmentsunder $250 in value. Since Mexican pottery is relativelyinexpensive, a large amount can be brought into the


A mobile laboratory (above left), equipped withbasic analytical instruments for performing fieldexaminations, arrives at a work site where a cargovessei is ready to begin discharging imports. Inside the mobiie laboratory (above right), the inspectors are performing a conciusive fieid examination for net weight of canned pineappie. Corematerial In canned pineapple Is being checked(middle right) to determine if the amount presenti s w i t h i n t h e e s t a b l i s h e d s t a n d a r d . A t e a m o f i n

spectors are performing an organoleptic examination of imported frozen shrimp (below right) afterIt has been made amenable to testing through athawing process In the mobile laboratory. A shipment of cocoa beans Is being sampled (below left)in preparation for an immediate examination inthe mobiie laboratory for an on-the-spot determination for compliance.

j L .


A search for suspect pieces intended to hold foods isbeing conducted in the contents of a case of pottery(above left) to carry out a field test that wiii disclose thepresence of any amount of lead or cadmium. A readingis being taken (above right) after a qualitative chemicalanalysis was performed with a newly developed fieldtest kit that indicates the presence of lead or cadmiumin pottery. Although a labeling examination is beingmade (middle left) on a shipment of canned food, theinspector's primary concern is a search for abnormaltins which may indicate the need for a microbioiogicaianalysis in the District laboratory. An official sample isbeing col lected (below left) for confirmation by theDistrict laboratory of a defective seam condition detected in a shipment of canned goods.

Richard Klug (left), assistant for Import operations, Field ComplianceBranch, Division of Field Operations, Office of the Executive Directorof Regional Operations, joined FDA in 1962. Frank Bruno (center),chief inspector. International Section, Ne\« York District, joined FDAin 1960. Raymond V. MIecko (right), food and drug officer, DallasDistrict, joined FDA in 1959.


country at a small cost. Our experience has shown thatmuch of the inexpensive type cf Mexican pottery maybe highly adulterated with leachable lead in excess o]the current guidelines. On September 28, 1971, DallasDistrict detained 1,422 toy earthenware pitchers becauseof excessive leachable lead content. The shipment wasvalued at $94 but Customs required the filing of a formale n t r y.

^ At the port of Brownsville, Dallas District detained 96,816 pounds of frozen strawberries on September 27. This product was packed in 10- and 16-ouncepackages, and the principal display panels did not bear anet weight statement as required by regulation underthe Fair Packaging and Labeling Act. The sample onwhich this action was taken was collected by an FDAinspector while riding the "circuit."

• I n r e c e n t w e e k s w e h a v e r e c e i v e d n u m e r o u s i n

quiries from importers about how to meet compliancerequirements under law due to the increased coverageafforded by FDA's new circuit rider program. We believe this program will bring about a greater degree ofvoluntary compliance as importers realize that we arenow checking more entries.

In general, we believe our circuit rider pwgram isworking well. We are receiving*cooperation from Customs and brokers and there is no question that impor ters know that surve i l lance has increased. I t isevident that FDA's periodic visits to the various portsare beneficial in alerting Customs to problem commodities that should be sampled in our absence. Webelieve our increased coverage will result in more detentions of noncomplying products, greater voluntarycompliance, and most important, better consumer prot e c t i o n .

We intend to improve and update our coverage ofcontainerized imported products. This technological andprocedural innovation of handling cargo presents problems because inspection and sampling of merchandisein containers requires that the container be opened.However, FDA's obligation to the consumer must neverbe waived solely because of hardship to the importer.We in tend to establ ish l ia ison wi th conta iner izat ioncenters and container users, maintain "inspection stations" at the centers, and pre-select commodities forcoverage from our proposed RIE form to expand ourc o v e r a g e .

The development of cooperative agreements with industry groups will be encouraged. Formal, nationalagreements with strong industry groups which spell outthe responsibilities of each party will promote voluntarycompliance, reduce FDA coverage of the articles underagreement, and allow more FDA resources to be diverted to high priority import areas.

Saturation sampling of problem commodities will expand our coverage and should induce c^orrection ofspecific problems by foreign shippers. A coordinated,national effort of this type would demonstrate thatFDA's import policy is uniform; would open lines ofcommunications with importers, trade groups, andforeign shippers and consulates, increasing the pos

sibility of voluntary compliance; and would lead toinvitations to FDA to inspect foreign establishmentsand thus greatly broaden our coverage.

Overseas Activities. FDA will seek to encourage expanding foreign consultative type inspections, whererequests for inspection and consultative advice arereceived, especially in the area of foods where a specificproblem exists, and where foreign funds are madeavailable to underwrite costs. The possibilities of FDAconsultative inspections of foreign food processingplants are often suggested during importer hearings afterDistrict detentions, at conferences with importer associations and trade groups regarding problems causingmultiple detentions, in discussions with commercialattaches and foreign consulate representatives aftermultiple detentions of products, and during visits fromforeign government officials. These suggestions will beexplored.

FDA foreign consultative inspections offer advantages: Resolution of violations at the source can,through helpful recommendations, bring about rapidcorrection. A well planned consultative trip can reacha whole industry, country, or area and thereby broadenour coverage. Mutual exchange of information and cooperation with foreign government counterparts of FDAcan be enhanced.

The Food and Drug Administration will also exploreways to increase the number of cooperative agreementswith foreign governments so that the policing of productscoming from those countries can be shared, thereby reducing the need for FDA surveillance of the productsunder agreement. All agreements will be formal, nationalin scope, and will set forth the responsibilities of eachpar ty.

Plans for implementation of the import coveragestrategy are now under full momentum. As previouslymentioned, the ship-to-ship and circuit rider methodsare presently under pilot study. As the foregoing reportson these programs indicate, their initial results are quiteencouraging. New York District has already determinedthat even a mobile laboratory that is not self-containedand that is equipped with only basic analytical equipment is proving useful in its import operations, especially in the ship-to-ship program. FDA has purchasedits first three completely self-contained mobile unitsthat can expand the number of analytical methods thatcan be performed in the field and thus can produce evenbetter results. Delivery of these first units is expected byJanuary 1, 1972.

Specific operating procedures for many of the programs in the strategy are being established. An initialconference for formal implementation of the strategy isplanned for early January 1972.

As the world of imports changes, so must FDA'scoverage, if it is to keep in step. We believe the newEDRO/field import coverage strategy is a change thatwill keep us abreast of new transportation technologyand will afford the kind of protection concerningimported products that the American consumer haslearned to expect in the domestic food and drug supply.


The Ve te r ina r ian andDrug ExperienceReportingby Walter L. Graves, D.V.M.,andSilas L. McHenry, Ed.D.

Two years ago, a practicing veterinarian observed signs of lami-nitis in horses he had treated witha corticosteroid product. The horseswere being treated for either arthritis or tendonitis, and developedl a m i n i t i s a f t e r t r e a t m e n t .

The practitioner notified the drugmanufacturer, and talked to otherv e t e r i n a r i a n s w h o h a d a l s o o b s e r v e d

signs of lameness and inflammationin horses treated with this product.

Since the drug had been marketedfor several years, the manufacturerwas required by law to make anannual report of drug experiencesto the Bureau of Veterinary Medicine. Such reports as the veterin a r i a n ' s a r e i n c l u d e d i n t h e s e c o m

pany reports.After receiving the drug firm's

periodic report for the corticosteroidproduct, the Food and Drug Adm i n i s t r a t i o n o b t a i n e d a d d i t i o n a l i nformation by interviewing manypracticing veterinarians who had observed adverse effects among horsesfrom use of this product. FDA alsos e a r c h e d t h e l i t e r a t u r e o n l a m i n i t i sfor any reference to this problem,b u t f o u n d n o n e .

As part of the invest igat ion,B V M a s k e d t h e F D A D i s t r i c t w h e r ethe drug company was located tomake an inspection of the company's complaint file on the productt o c h e c k o n o t h e r a d v e r s e r e a c t i o n

reports. The law requires that am a n u f a c t u r e r m u s t e s t a b l i s h a n dmaintain a complaint file at hisplace of business.

A s a r e s u l t o f t h e i n f o r m a t i o n

provided by veterinary practitioners,the firm voluntarily revised thelabeling, which was submitted toFDA and subsequently approved.

Demonstrating the application of apesticide to ki l l catt le grubs isWalter L Graves, DVM, chief of theS u r v e i l l a n c e B r a n c h o f t h e D i v i s i o nof Veterinary Medical Review. Inthis method of application the solution is poured over a beef animal'sback to kill insect larvae under theskin. The animals may be t ieds i n g l y f o r t r e a t m e n t o r d r i v e nthrough a chute, as shown, forfaster handling.


Examining a horse for arthritis areH. Dwight Mercer, DVM, deputyd i r e c t o r o f t h e D i v i s i o n o f V e t e rinary Research, wi th Si las L. Mc-Henry, Ed.D., industry informationo f fi c e r .

The new labeling includes theseprecautions: "Corticosteroids haveb e e n u s e d i n t h e t r e a t m e n t o f l a m i -nitis. (This product) is not reco m m e n d e d f o r t h i s u s e . C a s e s o flaminitis have been reported following* the administration of (thisproduct). Care is necessary whenusing any corticosteroid in theequine species." Because the reactions to this drug occurred at thehigher dosage levels, the maximumrecommended dosage in the labelingw a s r e d u c e d .

These changes improved thesafety of the product usage—due tothe alertness shown by practicingveterinarians and prompt follow-upby FDA.

When a New Animal Drug Application is approved, it often is notpossible to foresee all the problemsthat might be encountered in theroutine use of a product by differenti n d i v i d u a l s u n d e r v a r i o u s c o n d itions. It soon becomes apparentthat reporting of experience by usersis essential to bring about anynecessary changes to increase thesafety and efficacy of veterinarydrugs.

The Food and Drug Administration considers it extremely important that veterinarians report toFDA any adverse drug reactions or

unexpected responses associatedwith the clinical uses of a drug.A general rule might be that anunexpected response or an adversereaction is one that requires achange in treatment from that whichthe clinician had originally planned.

A veterinarian may consider anunexpected response to treatmentby a drug as an idiosyncrasy of anindividual animal. However, it isimportant that he report all adversereactions, whether or not they arede te rm ined t o be a t t r i bu tab le t othe drug, since the individual casemay be found to follow a patternsimilar to that of other reportedcases wh i ch a re assoc ia ted w i t h t he

drug in question. In addition, investigations of individual cases mayprovide a clue to the cause of ther e a c t i o n .

A new animal drug undergoesextensive pretesting by the drugfirm and careful review by FDAprior to approval, but constant surveillance by veterinarians is necessary for the detection of long-termeffects by pinpointing conditions of.use that may result in adverse reactions. Reports by practitionersmay provide the basis for modification of product labeling, such asdosage adjustments and the addition of precautionary statements.

Such modifications may result inincreased safety and efficacy of theproducts involved.

An unexpected response may bepeculiar to a particular lot or batchof the drug; it may be associatedwith the stability of the drug; or theproblem may be due to a mix-up inpackaging or labeling. Such problems may be eliminated if practitioners report their experiences toFDA's Bureau of Veterinary Medic i n e .

Recently an adverse reaction report was received by a firm thatmanufactures a drug used in killinglice and grubs (Hypoderma) oncattle. The rancher using this product reported an adverse reactionand dea th i n a l l an ima ls o f onebreed, but no significant adverseeffect in another breed. A veter inarian's diagnosis was drug toxicitydue to breed hypersensitivity to thedrug. The drug firm is being instructed by the Bureau to revise thelabeling to include a warning thatthe product should not be used onth is one b reed .

This case indicates that a drugmay be considered safe and effective for some species (or breedswithin a species) of livestock, butnot in others. I t demonstrates theimportant function performed by


t h e S u r v e i l l a n c e B r a n c h i n t h eBureau of Veterinary Medicine'sDivision of Veterinary Medical Rev i e w . T h i s B r a n c h m a k e s r e c o mmendations concerning these drugs,after it has taken the followinga c t i o n :

1. Review of the regular andspecial drug experience reports submitted by drug firmsi n a c c o r d a n c e w i t h t h e r e

quirements in the Code ofFederal Regulations.

2 . R e v i e w o f e s t a b l i s h m e n t i n

spection reports.3. Review of complaints and re

ports by veterinary practit i o n e r s .

4. Review reports from veterinary colleges.

In addition to these reports, theSurveillance Branch monitors publ i s h e d l i t e r a t u r e f o r i n f o r m a t i o n

concerning possible side effects ofveterinary drugs.

Ano the r sou rce o f i n f o rma t i onfor the Branch is the "VeterinaryAler t to Adverse React ion" (Form1932a), which is postcard size,franked, and self-addressed to theB u r e a u — t o r e d u c e t h e t i m e r equired for making the reports. Thiscard form alerts BVM to an unusualdrug experience, but is not largeenough for complete and comprehensive detai ls. A letter-size form(1932) is presently used as a follow-up by FDA to obtain additionalinformation. Later, this Form 1932will be required for all drug manufacturers to submit with their periodic reports.

During the 12-month period ending in July, 46 alert cards were received from practitioners and 35from contract colleges. These blankforms are distributed to practicingveterinarians by FDA District veterinarians, extension veterinarians,colleges of veterinary medicine, diagnostic laboratories, and State veterinary medical association secretaries. Three veterinary colleges areunder cont rac t to FDA to submi tdetailed reports of adverse reactionsoccurring in their clinics.

The Surveillance Branch is doingwork that is va luable to the users of

veterinary drugs. During the 1971

fiscal year, 1,629 drug experiencerepor ts were rev iewed by theB r a n c h . T h i s i n c l u d e d N e w A n i m a l

Drug Applications and VeterinaryAntibiotic Drug Experience Reports. From these reports, 212 reactions involving a total of 95,000poultry and 1,250 animals weren o t e d . T h e B r a n c h a l s o r e v i e w e d138 prescription drug advertisements in professional journals.

Approval for a drug may be withdrawn by the FDA if new informat i o n s h o w s t h a t :

1. The drug is unsafe.2 . S u b s t a n t i a l e v i d e n c e o f e f f e c

tiveness is lacking.3 . T h e r e i s a n u n t r u e s t a t e m e n t

in the New Drug Application.4. The required records have

n o t b e e n m a i n t a i n e d o r r e

ports submitted.5. Controls are inadequate.6. Labeling is false and mislead

ing.A f e e d m i l l c o n s t i t u t e s a c o m

mercial operation and falls withinthe purview of the Food, Drug, andCosmet ic Act . Under th is s ta tute,no medicated feed may be manufactured by a feed mill unless it isprior sanctioned or, as in the caseof a new animal drug requiring priorclearance, the mill holds the requisite approval and the product is correctly labeled. Therefore, the feedmill is not permitted under the lawto mix drugs with a feed in a formula not permitted under the law.

even when such a formula is prescribed or requested by a veterinari a n .

Some New Animal Drug Applications are being referred to theSurveillance Branch by the NAS/NRC (National Academy of Sciences/National Research Council)for review as possible "similar"drugs. More are expected in the future, since there were approximately700 NADA's reviewed by NAS/NRC—and also some NADA's thatw e r e n o t r e v i e w e d . A s a r e s u l t o fthese reviews, the manufacturers ofmany more products will be required to submit Drug ExperienceReports.

When a drug company prepares aDrug Experience Report, it is helpful to the Bureau if all pertinent datarelative to the drug is included. In-fonnation on the quantity of druga d m i n i s t e r e d a n d r o u t e o f a d m i n i st r a t i o n i s e s s e n t i a l . F D A w o u l d l i k eto know the length of illness, treatment, and information about anypossible adverse reaction to medication previously administered. Thedata should also include the breed,weight, age, and sex of the animalpatient.

These reports are divided intothree groups: (1) the periodic reports which must be submitted atintervals within six months duringthe first year and at yearly intervalsthereafter; (2) the reports that mustbe submitted within 15 working

Making a policy decision about the withdrawal of a New Animal DrugApplication after reviewing drug experience reports and other pertinentdata are C. D. Van Houweling, DVM, director of the Bureau of VeterinaryMedicine, and Fred J. Kingma, DVM, deputy director.


days of their receipt by the applicant; and (3) the reports that mustbe submitted immediately.

The kinds of reports that must bereported periodically are completerecords and reports of clinical experiences, both published and unpublished, that are pertinent to thesafety and effectiveness of the drug—or to the adequacy of the manufacturing procedures and controls.These experiences could be studies,investigations, or tests conducted bythe applicant or reported to him.Also required in the periodic reports are copies of all mailing piecesand other labeling and—if it is aprescription drug—all advertising,including copies of the currentlyused package labeling that gives fullinformation for the use of the drug.The copies of the currently usedpackage labeling are required,whether or not this labeling is contained in the application. The quantity of the drug distributed must bereported in a manner that makes iteasy to estimate the number of animals possibly affected.

The kinds of reports that mustbe made immediately (upon receiptby the apphcant) are complete records and reports covering any incidence of drug or label mix-up orsignificant contamination, deterioration, or failure to meet specificat i o n s .

Records and reports that must bes e n t t o t h e B u r e a u w i t h i n 1 5 w o r k

ing days of their receipt by the applicant cover unexpected reactionsor unexpected incidents of severityof a "reaction associated with thedrug's use—whether or not it isattributable to the drug and regardless of the length of time it has beenmarketed. Such reactions could beunexpected side effects, such as injury, toxicity, or sensitivity. This includes any unusual failure of thedrug to exhibit its claimed pharmacological activity. The requirementsfor filing these special reports applyto all holders of New Animal DrugApplications.

The Survei l lance Branch of theBureau evaluates the safety and efficacy of marketed veterinary drugs,and animal ( inc luding poul t ry)

V E T E R I N A R Y A L E R T T O A D V E R S E R E A C T I O N

V E T E R I N A R I A N ' S N A M E A N D A D D R E S S

O W N E R ' S N A M E A N D A D D R E S S

F o r m A p p r o v e dO M B N o . S 7 . R 0 0 2 6

I D A T E R E P O R T E D

I M E D I C A T I O N G I V E N B Y

I M A N U FA C T U R E R ' S N A M E

TAGE TSEX IWEIGHT IDOSAGE fo rm (Tab , i n j , e t c )

T O TA L D A I LY D O S E I R O U T E O F A D M I N I S T R A - D AT E O R D AT E S O F A D M I N I S T R AT I O NG I V E N I t I O N ( O r a l , I V , T o p i c a l , e t c )

P R I M A R Y D I A G N O S I S

F Y P E O F A D V E R S E R E A C T I O N O R L A C K O F E F F I C A C Y

PD FORM 1932a (1/71) P R E V I O U S E D I T I O N I S O B S O L E T E .

- F O L D H E R E ( T h i a a i d e i r O '

ADDITIONAL COMMENTS (I f any)

feed. It also, when appropriate, recommends action to correct significant hazards or potential dangersthat may result when directions,warning statements, and customaryinformation on the label need revis i o n .

The Branch conducts continuingsurveillance and medical evaluationof clinical experience. It reviewsestablishment inspection reports andother findings that may indicatewhether new drugs are being marketed in accord with commitmentscontained in New Drug Applicat i o n s .

The Branch obtains and evaluates reports of adverse animal drugreac t ions , and rev iews consumerand practicing veterinarians' complaints and reports. It makes recommendations concerning withdrawal of approval of NADA's.

FDA requests the cooperation ofall veterinarians in reporting casesof unexpected effects from clinicaluse of drugs. With their help, wecan continue to improve drug quality, safety, and truthful labeling.This will benefit the entire livestockindustry, including veterinarians.The "alert" cards make it easy todo. Additional information may beo b t a i n e d f r o m t h e S u r v e i l l a n c eBranch, Division of VeterinaryMedical Review, Bureau of Veterinary Medicine, Food and Drug Administration, 5600 Fishers Lane,Rockville, Maryland 20852.

The Veterinary Alert card (FD Form1932a) shown serves to call FDA'sa t t e n t i o n t o a n a d v e r s e r e a c t i o nobserved by a practicing veterinari a n .

Walter L. Graves, DVM, is chief of theSurve i l lance Brance o f the Bureau o fVeter inary Med ic ine 's D iv is ion o f Ve terinary Medical Review.

Silas L. McHenry, Ed.D., is industryi n f o r m a t i o n o f fi c e r i n t h e B u r e a u o fVeterinary Medicine.


Proving the Safety of Food Additivesby Leo Friedman, Ph.D., and Alan T. Spiher, Jr., J.D.

WOafety" has already become a keyword for the 1970's.^ Safety in the streets, safety of our environment,safety of drugs, safety of automobiles, and safety of foodadditives are examples of the concerns of consumers andgovernment officials alike. As with many words, understanding among interested persons is difficult, becausethe word "safety" means different things to differentpeople. The assurance of safety through premarketingclearances further complicates communication, particularly with the consumer. We propose to examine theproblems of proving safety under the premarketingclearance requirements for food additives as establishedby the Food Additives Amendment to the Federal Food,Drug, and Cosmetic Act.

The following is part of an address by Leo Friedman,while a university professor, at a 1969 symposium onthe Evaluation of the Safety of Food Additives:

"We can all agree that tests on experimental animalscannot provide proof of the safety of a substance forthe human species; for that matter, neither can experiments on human beings. The ultimate tests will beprovided by experience in everyday use, and then onlywhen we have much more sophisticated and effectivesurveillance of the health of the population so that weare capable of detecting more than the usual strikingeffects, and are better equipped to associate cause witheffects far removed in time. But we know that studiesin experimental animals are useful and essential.

"Safety evaluation at the present time is founded onthe concept of the 'maximum no-effect dose.' Theprocedures are all designed to determine the largestdaily intake over extended periods (including a lifetime) that will not produce the injurious effects characteristic of the substance when given in larger, that is,toxic amounts; and just as important, to exclude thepossibility that these subtoxic amounts will producesome hitherto unsuspected reaction.

"Theoretically, if all the biochemical and physiological interactions of a substance and an organism, inevery phase of its development, were known, one couldd e t e r m i n e w i t h c o n s i d e r a b l e c o n fi d e n c e t h e l e v e l o f

exposure that would assure no probability of harm.Although ultimately the critical information is at theb o r d e r l i n e b e t w e e n a b n o r m a l a n d n o r m a l f u n c t i o n i n

the cell, for some time we must continue to rely on therelatively crude studies in experimental animals fromwhich we extrapolate conclusions regarding people. Wemust be particularly alert for the unexpected and constantly review our experimental approaches and designsfor holes that will permit deleterious effects to go und e t e c t e d . "

The inherent difficulties in proving safety, therefore,require that toxicity studies of food additives be carefully designed and conducted. Any risk of undetecteddeleterious effects must be at an acceptably low level.Adequate margins of safety must be provided to protectagainst errors in the translation of effects from animalsto man. The presence of a new substance in food mustbe consistent with a Federal regulation promulgated toprescribe the conditions under which the substancemay be safely used, including the requirement that itmay not be used at a level higher than reasonablynecessary to accomplish the intended physical or othertechnical effect. For purposes of establishing the properregulation, the Commissioner of Food and Drugs musthave full and complete reports of studies properlydesigned to establish that the additive is safe for itsi n t e n d e d u s e .

Evaluation of safety includes an estimation of thepotential of the substance to cause injury and reviewand evaluation of sufficient data to warrant a conclusion that the conditions of proposed use will providean intake so low in relation to the toxic dose thatthere is a practical certainty no harm can result. Thisinformation can usually be obtained only by studiesin animals. The problems of designing animal experiments include uncertainty that the animals chosen areappropriate models from which to extrapolate theresults to humans, and difficulty in detecting (with thelimited number of animals that ordinarily can be used)any effects that would occur in a very low incidence.

Although the difficult scientific questions posed andthe great practical significance of the results mightbe expected to have challenged competent toxicologiststo apply their independent efforts to develop answers,in practice the industrialist has looked to the FDAfor guidance. Recommendations on safety testing byFDA first appeared in 1943, succeeded by a more

FDA Papers / November 1971 t 13

comprehensive series of articles in 1949. These wererevised in 1955 and again in 1959 under the title,"Appraisal of the Safety of Chemicals in Foods, Drugs,and Cosmetics." Many developments in toxicologyhave occurred since 1959 so that a revision today istimely. We have benefited from many advances inprocedures and analytical techniques for metabolicstudies; a greater availability of radioactive-tagged substances; and a clearer understanding of the microsomalen2ymes and their role in metabolic conversion. AnFDA advisory committee has recently emphasized theimportance of including reproduction, teratogenesis, andmutagenesis data in safety evaluations. Carcinogenesistesting has been reviewed during the past few years byseveral national and international public committees.

Obviously, to keep the risks of undetected deleteriouseffects at a minimum, and to assure that the observedeffects are not spurious, the safety evaluation studiesmust be properly designed and the results must besubject to adequate interpretation. Also essential is themaintenance of laboratory management and practiceto prevent or minimize contamination of food, water,and equipment; to minimize the incidence of intercurrent disease; and to assure adequate records andthe preservation of important experimental materials.Basic minimum requirements in the design of studieswith test animals include observations on growth, foodintake, clinical manifestations, hematology, blood chemistry, urinanalysis, gross pathology, and histopathology.Additional observations or tests should be included,either as a direct result of observations made duringinterim sacrifices of animals, or as a result of priorknowledge based on structural similarities of the additive to compounds studied previously or on earlierscreening studies, either acute or subacute. Specificstudies that may be required include the following:

(1) Acute toxicity in several species of experimentalanimals with emphasis on providing a full and complete description of the effects observed, includingobservations at death.

(2) Cumulative toxicity during a period of intermediate duration. This has been the tradit ional subacute toxicity test of 90 days. We now recommendthat this study extend from time of weaning to sexualmaturity, including reproduction according to protocolsdesigned to produce valid data that will permit calculation of indices of reproductive performance, and including mutagenicity and teratogenicity. Such data shouldbe derived from more than one species of animal,including at least one nonrodent species (as a practicalmatter, subacute reproduction tests should include anonrodent species). Full and complete observations

are to be reported, including gross and microscopicexamination of tissues, either at death or at sacrifice.

(3) Data on changes that may take place in theaddit ive due to interactions of the addit ive with thefood containing the additive during storage and preparation for consumption.

(4) Data, from both short-term and long-term administration in several species of animals, on absorption, distribution, metabolic transformations, excretion, tissue distribution, and accumulation.

(5) Establishment, by studies, that the metabolicpattern of the test animal chosen is closest to man sothat similar responses to the test agent may be expected.

(6) Initiation of chronic or long-term (lifetime inanimals having short life spans) studies by administration of the test agent to the female prior to conceptionof the offspring to be used in the lifetime studies. Inthese studies, animals should undergo at least two cyclesof reproduction according to protocols designed to givevalid teratogenic and mutagenic data. The designshould provide enough animals for interim sacrifice andstudy. We would urge that the chronic tests be combined with a three-generation reproduction test, andthat the Fi generation be used for the lifetime study,so that the exposure starts at conception. More thanone species should be used for carcinogenesis evaluation.

(7) Whenever indicated, other specific tests; forexample, teratogenic and mutagenic tests, and in thecase of organo-phosphate and carbamate pesticides,cholinesterase inhibition and demylination studies mustbe made. In the case of compounds containing nitro-phenol groups in the molecule, cataractogenic studiesmay be required.

The changes in familiar protocals are not extensive.However, there are other areas of concern where suitable protocols have not progressed beyond the earlystages of development and are not now ready for"routine" testing purposes. These include allergy, sensitization, photosensitization studies, and studies of foodproducts made from new and unusual raw materials,food processed by new processing techniques, and foodsderived from animals and plants modified by breedingand selection. Also under study are new approachesto the evaluation of experimental data with a view toa more rational estimation of potential hazard undervarious conditions of use. Progress on these problemsmay well result in the periodic announcement of newtoxicological criteria. The creative input of industrialtoxicologists or industry-supported academic researchwould be very useful to all in helping to resolve theseproblems.

Emphasis should be made also on the importance of


statistical evaluation procedures, including errors ofthe "second kind." Errors of the first kind are thoseuncertainties involved in a positive conclusion. Conclusions based on negative data that there is no adverseeffect may contain errors of the second kind. Theseuncertainties tend to be generally overlooked and thisleads to acceptance of sloppy work and questionableresults as evidence demonstrating safety.

Obviously, the suggested requirements can be modified, depending on the known facts about a proposednew additive. Adjustments also may be possible on thebasis of human data when such information is available. The extent and depth of the toxicological investigation of a substance to be added to food dependson the estimated daily intake, the findings during theinvestigation, and the nature of the substance itself.Where strong or alarming biological effects are observed, it may be necessary to proceed with additionalanimal studies before an acceptable daily intake ofthe additive can be set or, if the effect is carcinogenic,to prohibit use of it in food.

We have set forth the requirements we believe, inthe current state of our knowledge, should be met forthe proper evaluation of the safety of a new fooda d d i t i v e . I n t h e c a s e o f s u b s t a n c e s t h a t h a v e b e e n i nuse many years, sometimes many generations, suchas some of the materials on the GRAS List, it is difficult to reconcile a long history of apparently safe usewith the need for additional study in experimental animals or, indeed, with adverse findings in experimentala n i m a l s . T h e t r a n s l a t i o n o f a n i m a l d a t a i n t o c o n c l usions about human safety is, under the present conditions, fraught with uncertainty. Nevertheless, the merehistory of human use can tell us only that our presentstate of public health is in equilibrium with the exposures we are experiencing. Just as there is a greatdeal of uncertainty in judging that adverse findingsin experimental animals will mean deleterious' effectsin human beings under similar conditions of exposure,so there is a great degree of uncertainty in concludingthat the removal of traditional sources of exposure onthe basis of adverse findings in animals will not resultin an improvement in the current state of public health.

We must make our judgments at present on the basisof the best scientific data available. Whenever this information is obtained by human experimentation, itwill have a much closer relevance to the human condition, but we must remember that mere experience issimply a reflection of an equilibrium situation.

As in the past, FDA toxicologists are ready to consult with petitioners over the data necessary for specificpetitions.

Alan T. Spiher, J r. , J .D. , ch ie f , GRASR e v i e w B r a n c h , D i v i s i o n o f P e t i t i o n s

Process ing, Office of Compl iance, Bur e a u o f F o o d s , i s p r o j e c t m a n a g e r ,GRAS List Review, and program manager, food addit ives.

Leo Fr iedman, Ph.D., is d i rector, Div is ion of Toxicology, Office of Sciences,B u r e a u o f F o o d s .

FDA Papers I November 1971 / 15

B O T U U S Mby Donald A. Kautter and Richard K. Lynt, Jr.

In Bedford Village, New York, last June two personsate commercially prepared canned soup unhealed fromthe can; both became seriously ill, and one died. InPhiladelphia in August three people became ill aftereating home-canned green peppers and one died. AtBakersfield, California, in mid-September seven adultsat a family meal tasted or ate chili sauce prepared fromhome-canned peppers and one died and six others became ill, one mildly, two seriously, and three critically.

In all instances the foods involved contained botu-linum toxin, produced by the bacterium Clostridiumbotulinum, and the deadliest poison known to man.After the New York incident, the FDA, verifying thepresence of botulinum toxin in the soup, produced bythe Bon Vivant Company, Inc., of Newark, New Jersey, instigated a recall of all soup in that lot, and later,unsatisfied with the progress of the recall and with themanufacturing controls used by the company in canning soups and other foods, acted to remove all thecompany's products from the market until questionsconcerning their safety could be resolved. In Augustthe FDA announced that the Campbell Soup Companywas recalling a lot of chicken vegetable soup producedin July in which the company had found C. botulinum.The soup was recalled before causing illness.

Botulism is a severe type of food poisoning causedby the ingestion of foods containing a potent neurotoxin formed during growth of Clostridium botulinum,a spore-forming bacterium for which oxygen is toxic.The incidence of the disease is low, but it has beenthe cause of considerable concern because of the extremely high mortality rate. The majority of the 10 to20 outbreaks reported annually in the United States areassociated with inadequately processed home-cannedfoods. Botulinum toxin is produced by the growth ofthe organism in the food material before it is consumedand thus the disease is an intoxication and not a food-borne infection.

The organism is widely distributed in nature andoccurs in both cultivated and forest soils, bottom sediments of streams, lakes, and coastal waters, the intestinal tracts of fish and mammals, and the gills and viscera of crabs and other shellfish. Sausages, meat products, canned vegetables, and seafood products havebeen the most frequent vehicles for human botulism.Six antigenic types of toxin are produced by differentmembers of the species and these form the basis ofclassification of the organism into types A through F.Types A, B, E, and F have been responsible for human

cases; types C and D are associated with botulism ina n i m a l s .

Although botulism has been known since ancienttimes, only in the last 200 years has there been sufficient knowledge to recognize it as a foodborne disease.It was first accurately described and made a reportabledisease in southern Germany in the early nineteenthcentury after a study of more than 200 cases of poisoning from sausages. The term "botulism" (botulus,Latin-sausage) was first applied to this syndrome in1870 and the causative agent was first isolated anddescribed by Emile-P. Van Ermengem in 1896. Henamed the organism Bacillus botulinus (now Clostridium botulinum).

Until the causative agent was identified, botulismwas thought to be associated exclusively with sausagesor meat products, but shortly afterward one outbreakin Germany and another in California were traced tobean salads. However, the toxin produced by the strainsisolated in both cases was immunologically distinct fromthat of Van Ermengem's strain. These incidents werefollowed in the United States by a series of outbreaksthat were traced to canned vegetables and fruits. Statistics for 1918 through 1922 show 83 outbreaks with297 cases and 185 deaths. Since then the occurrenceof botulinum toxin in commercially canned foods hasbeen reduced by improved canning methods that resulted from research sponsored by the canning industryand public health authorities.

All of the outbreaks reported through 1922 were dueto organisms producing one or the other of the twoabove types of toxin, later designated as types A andB. Both of the type C subtvpes (C. Alpha and C. Beta)and type D were reported in 1922. Types C and Dhave caused heavy losses of chickens, ducks, aquaticwildfowl, cattle, horses, and mink, but there is littleevidence that they have ever been responsible for humanbotulism, although there is no evidence to indicate manis not susceptible.

Type E was first identified as a toxigenic type in1935. This strain, isolated from Russian sturgeon, wasfound to be identical to two other strains previouslyisolated in New York. One strain had been isolatedfrom an outbreak in 1932 involving salmon caught andsmoked in Labrador and the other from importedcanned sprats responsible for an outbreak in 1934.Although one type E outbreak was due to commerciallycanned mushrooms in 1941, the majority of outbreaksin the United States have been associated with fishand seafood. Since 1960, outbreaks traced to fish


caught and commercially smoked in the Great Lakesarea have been responsible for 21 cases and 9 deaths,but one outbreak responsible for two deaths in 1963involved canned tunafish. This organism is an important public health hazard in areas of Japan where"Izushi," a dish made of fermented raw fish, rice, koji,and chopped vegetables, is a popular food. It has givenrise to morbidity rates from type E botulism of about50 percent with fatality rates of 20 percent to 100percent.

Type F was first isolated in 1960 from an outbreakin Denmark in which a liver paste was the vehicle.The only other type F outbreak on record occurredin California in 1966 and was traced to contaminateddeer jerky.

The disease, botulism, occurs throughout the world.Of the 659 outbreaks recorded in the United Statesfrom 1899 through 1969, 21.8 percent were due to typeA, 5.6 percent to type B, 2.6 percent to type E, and0.3 percent to type F. In 69.5 percent of the outbreaksthe type was not determined. Outbreaks have beenreported in 44 States, but five Western States accountfor over half of all reported outbreaks.

Of the 144 type A outbreaks, 92 percent were inStates west of the Mississippi River, whereas 25 of37 type B outbreaks, or 67 percent, occurred in Eastern States from 1899 through 1969. Type E outbreakshave been reported in 10 States. The geographic association of this type with Alaska and the Great Lakesarea may be more apparent than real.

The regional distribution of outbreaks by toxin typeis in keeping with the results of a spore survey of soilsamples by K. F. Meyer and B. J. Dubovsky. Theseinvestigators found a predominance of type A in soilspecimens from the West and of type B in soils of theNortheast and Central States. Other investigators haveshown that type E is the predominant type in fish andsediments from the Great Lakes, in estuarine andcoastal waters, and in sediments, fish, and shellfishfrom the Atlantic, Pacific, and Gulf coasts of NorthA m e r i c a .

In Europe, type B is the predominant type both insoils and in outbreaks. However, type E has accountedfor 46 percent of the outbreaks in Japan, Canada, andScandinavia in the Twentieth Century.

The types of foods involved in botulism vary according to food preservation and eating habits in different regions. Almost any type of food with a pHabove 4.5 can support growth and toxin formation.Botulinum toxin has been found in a considerable variety of foods, such as canned corn, peppers, green beans,beets, asparagus, mushrooms, ripe olives, spinach, tuna-fish, chicken and chicken livers and liver pate, and inluncheon meats, ham, sausage, stuffed eggplant, lobster,a n d s m o k e d fi s h .

Foods that have been involved in outbreaks of botul ism in the Uni ted States between 1899 and 1969,identified mainly on the basis of clinical symptoms instead of isolation and typing of the organism, include:

vegetables—395 outbreaks of which 362 involvedhome-preserved foods; meat—44 outbreaks, 36 home-preserved; milk and milk products—7 outbreaks, 5home-preserved; fish and seafood—48 outbreaks, 33home-preserved; and fruit and pickles—35 outbreaks,of which 34 involved home-preserved foods. In manyo u t b r e a k s t h e k i n d o f f o o d i n v o l v e d w a s n o t i d e n t i fi e d .

M o s t o f t h e o u t b r e a k s h a v e b e e n t r a c e d t o h o m e -canned vegetables, fruits, fish, and meat products, witha smaller number involving commercially processedfoods. Although many outbreaks were caused by commercially canned products during the 1920's and 1930's,home-canned string beans, corn, beans, spinach, andasparagus accounted for over half of the total number.

U.S. Department of Agriculture Home and GardenBulletins on safe methods of preserving and handlingfoods in the home are for sale by the Superintendent ofDocuments, Government Printing Office, Washington,D.C. 20402: #8—Home Canning of Fruits and Vegetables, #40—Freezing Combination Main Dishes, and#174—Meat and Poultry—Care Tips for You, all 20cents each; #106—Home Canning of Meat and Poultry and #70—Home Freezing of Poultry, 15 cents;#93—Freezing Meat and Fish, 25 cents; and #162—Keeping Foods Safe to Eat, 10 cents.

Botulism is usually associated with foods that havebeen given a preservation treatment, stored for sometime, and consumed without appropriate heating. Thegrowth of C. botulinum in foods frequently, but notalways, produces a foul, rancid odor, that serves as awarning to the consumer. Signs of spoilage, however,have not prevented botulism because the degree oftolerance to disagreeable odors or off-flavors variesamong individuals. Moreover, in foods that are smoked,heavily spiced, or fermented, the off-odor may be difficult to recognize.

Botulinum toxin causes paralysis by blocking motornerve terminals at the myoneural junction. Paralysisprogresses downward, usually starting with the eyesand face, to the throat, chest, and extremities. Whenthe diaphragm and chest muscles become fully involved, respiration no longer is possible and death fromasphyxia results.

Early signs are marked lassitude, weakness, andvertigo, usually followed by double-vision and progressive difficulty in speaking and swallowing. Difficulty inbreathing, weakness of other muscles, abdominal distension, and constipation also are common symptoms.Type E, in addition, may cause severe nausea andvomiting in the early stages, and redness of the upperthroat area and difficulty in urination later. The intervalbetween the onset of symptoms and death in a seriesof cases analyzed in Japan varied from 8 to 28 hours,but in those who recovered, some symptoms such asthirst, weakness, throat pain, and abdominal swellingpersisted for some time.

Although botulism can be diagnosed on clinicalsymptoms alone, differentiation from a variety of otherdiseases often is difficult. Initial mis-diagnosis as other


central nervous system disorders, such as bulbar poliomyelitis, is not uncommon.

Clostridium botulinum is a large, flagellated, spore-forming bacillus. As noted, it is anaerobic, that is, willnot grow in the presence of oxygen.

Since botulism is foodborne and results from ingestion of toxin formed in the food following growth ofthe organism, determination of the source of an outbreak is based on detection and identification of thetoxin or cultivation of C. botulinum from the food involved. Currently the most widely used method for detecting toxin in suspect food is the injection of extracts of the food into passively immunized mice, andthe first objective in an epidemiological investigationis usually the detection of toxin in the suspected foodby such a test. Rapid identification of the toxin is important for proper treatment of the victims and forascertaining the source so that the implicated food canbe removed from further distribution as quickly aspossible. This analysis is followed by culturing all suspect foods in an enrichment medium for the detectionand isolation of the causative organism.

The details of these procedures will vary somewhatwith the nature of the material to be examined. Products such as meat or fish are mascerated with gel-phosphate buffer to extract toxin, whereas liquid portions of some products can be injected directly intomice. Suspect foods are cultured for the bacillus because, on occasion, the food is no longer toxic at thetime the mouse test is performed. Human illness withsymptoms of botulism and isolation of a toxic strain ofC. botulinum from the food involved is considered apositive laboratory confirmation of the diagnosis evenin the absence of positive toxicity tests on the foodproduct itself.

There are many enrichment media used for thecultivation of the different types of C. botulinum. Themost common of all contain reducing agents to maintainanaerobic conditions as well as buffering agents.

The usual incubation times and temperatures formaximum toxin production and growth of the varioustypes range from 3 to 7 days, at 78° to 96°F.

Elimination of nonspore-forming contaminants fromenrichment cultures is performed in the laboratory byt r e a t m e n t w i t h a l c o h o l . C u l t u r e s a r e t h e n s t r e a k e d o n

plating media for the selection of typical colonies ofC. botulinum. Plating media frequently employed areblood agar, liver veal egg agar, brain heart infusionagar, a variety of beef infusion agars, and modificationsof special egg yolk media.

The majority of the known outbreaks of botulismhave been traced to foods given inadequate or minimalprocessing such as in home canning, and smoking orpickling foods to be served with little or no cooking, orwhen they are held for periods of time under inadequate refrigeration. Government agencies continue tourge home processors to use processes which haveproved to be safe, and the serving of home-preservedfoods in public eating places is prohibited in some

localities. However, the chief concern is with the safeprocessing of commercial products, which, if toxic,could affect large numbers of consumers in widely dispersed areas.

Fresh food, whether eaten raw or cooked, has notbeen implicated in an outbreak of botulism. Foodpreservation methods therefore must be designed toprevent the development of botulinum toxin unless thenature of the food itself is inhibitory to the growth ofthe organism. These are foods with a high acid, sugar,or salt content. Some of these are canned fruit juices,sauerkraut, many tomato products, heavily salted hams,jams, and jellies. Adequate preservation methods must,in order of preference, either destroy all spores, prevent their germination and the outgrowth of vegetativecells, prevent the development of toxin, or provideconditions under which any toxin that might be formedw i l l b e i n a c t i v a t e d .

The toxins of C. botulinum are heat sensitive and aretherefore readily destroyed by normal cooking. Boilingfor 10 minutes provides a reasonable margin of safetyagainst all types.

The real safety problem in food preservation, however, is the destruction of spores in processed foods. Ifthey are not destroyed, they may germinate, grow, andproduce toxin under favorable conditions. Spores inthemselves are not dangerous. Many are probably ingested by man under normal conditions, but indicationsare that they do not grow or produce toxin in theh u m a n i n t e s t i n a l t r a c t .

Freezing will not destroy either toxin or spores, butwill prevent the germination and outgrowth of sporeswhich would lead to toxin production at higher temperatures. It is most important that nonsterile frozenproducts be kept frozen until cooked.

C. botulinum is an obligate anaerobe, and atmospheric oxygen has a toxic effect on its vegetative cells.Its growth in food, therefore, is related to the oxidation-reduction (O-R) potential of the food itself. Such potentials are established in many foods by oxygen-reducing systems present in the food such as sulfur-hydrogen molecular groups that bind up oxygen inmeats; ascorbic acid or vitamin C, that binds up oxygenin many foods; and other micro-organisms that use upoxygen. No special conditions of incubation, therefore,are required for C. botulinum since frequently the fooditself produces a sufficiently low oxygen-reduction potential to permit outgrowth.

The resistance of C. botulinum spores to chemicalagents is quite high. For complete inhibition of sporegermination and outgrowth, 5 to 10 percent commonsalt (sodium chloride) is required.

Canning procedures have been developed to destroyspores with a sufficient margin of safety to make theprobability of any survivors extremely remote. Wherethere is a question about the safety of a product, cansshould be discarded when they show even slightly bulging ends or any other evidence of spoilage such assouring, gas formation, discoloration, or leaks. All such


Detecting and Confirming

B O T U L I N U MCans of food to be analyzedfor C. botulinum are openedaseptically (left) after chillingto prevent release of thecontents when the gaseouspressure that may be presentin the can is released. Flamefrom ignited alcohol is used tosterilize both the top of the canand the can-opening device.If the food is liquid as shownhere (bottom left), an aliquot ispipetted to a centrifuge tubeand centrifugates are made tobe analyzed for botulinumtoxin. If the food product issol id or semisol id, extracts areprepared (bottom center) byhomogenizing food in an equalportion with gel-phosphatebuffer in a grinding process.A microbiologist examines anextract of the food (bottomright) which will be centrifugedto be tested in mice for toxicitywithout further processing.

Mice are injected (right) with the liquidportion of food extracts or cell-freesubcultures to determine if toxin is present.If mice die within 72 hours it is presumptiveevidence of the presence of botulinum toxin.For determination of type-specific toxin,further tests are performed in mice bypassively immunizing groups of mice withantisera specific for C. botulinum types A, B,E, and F. If one group of mice receiving aspecific antitoxin lives and the other mice diewithin 72 hours, the type of toxin in the foodo r c u l t u r e h a s b e e n d e t e r m i n e d .

In preparation of subcultures for analysis, aportion of the food is cultured (above left) incooked meat or trypticase-peptone-glucose-yeast extract-trypsin (TPGYT) media. Thesecultures will be tested for toxicity after 5-7days incubation. The subcultures or extractsare streaked on an agar medium and grownunder anaerobic conditions (without oxygen).The atmosphere in the case-anaerobic jar(middle right) where the cultures will beincubated is being replaced by nitrogen gas.Nitrogen or hydrogen provides a satisfactoryatmosphere for growth of C. botulinum. Afteri n c u b a t i o n t h e s u b c u l t u r e s a r e e x a m i n e d

microscopically. This photo (right) showstypical cells and spores of C. botulinum at amagnification of about 4,500 times.

Rabbits are being used by FDAto produce antisera for cellsand spores of C. botulinum.T h e a n t i s e r a a r e u s e d i n arapid screening method beingdeveloped for detectingC . b o t u l i n u m b a s e d o nfluorescent antibodytechniques. Here (above left)a rabbit is being injected withan antigen. After an antiserumis produced in a rabbit, thea n i m a l i s b l e d . T h e a n t i s e r u mis separated from the otherb l o o d c o n s t i t u e n t s a n d f u r t h e r

prepared for use in thefluorescent antibody screeningtechnique for cultures andfood products. Some FDAmicrobiologists and laboratoryt e c h n i c i a n s w h o w o r k w i t hsuspect food samples andC. botul inum cultures daily aremore subject to accidentalexposure to botulinum toxinthan the average person.As a safety measure amicrobiologist is beingimmunized (bottom left) withpentavalent botulinum toxoidi n a P u b l i c H e a l t h S e r v i c eclinic. The growth of C.b o t u l i n u m i n c a n n e d f o o d screates a gaseous pressurethat usually, but not always,causes the can to swell, likethese shown (bottom right).The contents of cans or jarsthat indicate the slightestevidence of swelling shouldnot be eaten, nor tasted.

A microbiologist examines a sample (left)containing part of the contents of a jar ofhome-canned peppers that containedbotulinum toxin and was responsible for thedeath of one person and the illness of twoothers. The sample was supplied to FDA forcooperative confirmatory testing for C.botulinum. The photos below showfluorescing vegetative cells of the four typeso f C . b o t u l i n u m a s s o c i a t e d w i t h h u m a n i l l n e s s :at top left, Type A; top right, Type B; bottomleft. Type E; bottom right. Type F.

These unusua l pho tog raphs o f ce l l s andspores prepared by FDA were made througha scanning electron microscope at high magnifications and show (top left) a cell of C.botulinum, Type A, prior to sporulation, and(top right) another Type A ceil during actualsporulation. At bottom are spores of Type B(left) and Type E (right).


cans should be suspected as potentially botulogenic andexamined for toxicity and the presence of C. botulinum.Never under any circumstances should the contents ofsuch products even be tasted, let alone eaten withoutthorough cooking.

The canning industry, using the information provided by research carried out in the 1920's and 1930's,has adopted a standardized process for treating low-acid foods so that the probability of C. botulinumspores surviving is very remote. The spores of C.botulinum, although quite resistant, are not the mostheat-resistant known, and other more resistant spore-formers are frequently used in time-temperaturestudies. However, canning processes must be of suchlethality that the likelihood of C. botulinum sporessurviving is negligible. The concentration of spores ina food product is important because the greater thenumber of spores there are in the product, the greaterthe processing time and temperature required to insuretheir complete destruction. Therefore, the so-called12 D standardized canning process was designed toreduce a bacterial load of a billion spores in each ofa thousand cans to the level of one spore in a thousandc a n s .

These processes, which take into account amongother things the consistency and chemical nature of theproduct and the size of the can, are now standardizedto the point that only through recontamination afterheating is it likely that a significant degree of spoilageo r h a z a r d f r o m C . b o t u l i n u m c o u l d o c c u r . A n a d d itional safety factor is provided by proper sanitary control, as specified in FDA's Good Manufacturing Practice guidelines, which reduces the original bacterial loadto be inactivated during the canning cycle.

The knowledge concerning the effects of chemicals,such as salt, nitrite, and organic acids, on the germination and outgrowth of C. botulinum spores has beenutilized by the meat-curing industry to produce safeand acceptable products without subjecting them to the"12 D'" canning process.

The preservation of food by drying, or smoking anddrying, goes back beyond recorded history. Moderncommercial drying processes are superior to the crudesmoking-drying combinations of the past that weresometimes responsible for botulism. Freeze-dehydrationand conventional air drying are commercially attractivebecause of increased shelf life, weight reduction, andpackaging ease. Some type of pretreatment is usuallyrequired so that rapid freezing and dehydration cano c c u r .

Vacuum packaging provides special hazards whenf o o d s w i t h s u f fi c i e n t m o i s t u r e c o n t e n t t o a l l o w b a c t e r i a l

growth are placed in an environment that will discourage growth of normal spoilage organisms on thesurface, but will support the growth of anaerobes, suchas C. botulinum. In vacuum-packaged foods, growthof aerobic or oxygen-using organisms is considerablycurtailed, and the shelf life appears, therefore, to beextended because visible spoilage has not occurred.

This additional shelf life may be sufficient for anaerobes, such as C. botulinum, to grow and producetoxin. With vacuum-packaged foods, as with so manyothers, every attempt must be made to establish highlevels of sanitation in the processing plant so that contamination levels with C. botulinum will be held to am i n i m u m .

The radiation preservation of foods has been subjected to intensive study in recent years. Processes designed to pasteurize food by irradiation would havelittle or no effect upon the spores of C. botulinum,which are resistant to radiation damage. The extendedshelf life obtained by low-dose irradiation might allowoutgrowth and toxin production.

In any commercial operation for the preservation offoods, plant sanitation has an important bearing on theeffectiveness of processing in the elimination of thehazard from C. botulinum. If the spores are present inthe plant, they may gain access to the product throughhandling at any stage of the operation.

The ubiquity of C. botulinum, the resistance of itsspores to physical and chemical agents, and the lethalityof its toxin call for careful attention in the preparationof commercial food products. Thorough cleaning of allraw products in preparation for processing, scrupulousattention to sanitation in all phases of plant operation,and meticulous attention to processing conditions andthe handling of the finished product are required. Although certain types of products have been more frequently incriminated than others, it is probable thatalmost any food may become contaminated. As newtypes of processing and packaging are contemplated, itis especially important that they be designed to eliminate the hazard presented by contamination with C.b o t u l i n u m .

Donald A. Kautter, assistant chief,Food MIcrob lo iogy Branch, D iv ision of Microbioiogy, Bureau ofFoods, jo ined FDA in 1960.

R i c h a r d K . Ly n t , J r . , r e s e a r c hmicrobioiogist , Food MicrobioiogyBranch, Div is ion of Microbioiogy,Bureau of Foods, jo ined FDA in1 9 6 3 .


I « ' ~

ATLANTA DISTRICT James Shelton, product safetyconsultant in FDA's Region IV, took part in an orientation seminar on product safety held September 23 atJacksonville by the Florida Department of Health andRehabil i tative Services. Mr. Shelton was a moderatorfor the seminar along with A. W. Morrison of the Statehealth department. Sam Hart, deputy director of FDA'sBureau of Product Safety, provided comments and projections for the Federal approach to be followed in thearea of consumer protection. The program was wellreceived by the top staff people of the health department for whom the seminar was being held.

BALTIMORE DISTRICT The second phase of theFDA-VDAC personnel exchange is underway; the firstphase was earlier in 1971 (see FDA Papers, May1971 issue).

FDA Supervisory Inspector H. Thompson Price, Jr.,began a 60-day detail with the Virginia Department ofAgriculture and Commerce on October 4. During thisperiod, he will work under the direct supervision ofA. Lee Turner, supervisor of VDAC's Food RegulatorySection. Mr. Price will receive indoctrination in everyphase of the department's food inspection operations.

It is anticipated that this half of the exchange willbe as beneficial as the first phase when VDAC detailedHoward R. Haynie to FDA's Baltimore District Office.

BOSTON DISTRICT During July-September, over twomillion dollars worth of canned tuna imported fromJapan was denied entry into the United States throughthe New England ports. FDA's examination of thetuna revealed either decomposition or mercury contamination in excess of the 0.5 parts per million guideline set by the Agency.A U.S. District Court judge sitting at Boston signedan order of destruction September 20 that brought toa close an action that had been pending since earlyin 1970. On February 16 of that year a quantity ofveterinary drugs was seized at Harilian Pharmaceuticals, Inc., Greenwich, Connecticut, on a complaint offorfeiture charging the goods were new animal drugsfor which the firm did not have an approved NewAnimal Drug Application. The firm entered a claim

to the drugs and filed a consent decree, but by September of this year it had not brought the goods intocompliance and the recent court order was issued.

BUFFALO DISTRICT Import detentions recently haveincluded several products from the Peoples Republicof China that failed to comply with FDA's Fair Packaging and Labeling Act requirements. These articleshave been transshipped from Canada, where the producers have to a large extent taken steps to essentiallycomply with these regulations.

The District is concerned not only with such detentions but also with a recent problem that can vastlychange its import coverage. Oceangoing vessels havebeen docking at Albany, New York, rather than atNew York City. The boats apparently are making thetrip up the Hudson to unload at this inland port toescape the longer delays. If this practice continues, itwill bring about changes in Buffalo's import coverage.Bon Vivant Soups occupied a considerable portion ofthe District's time into the month of October. Cooperative action between the New York State Division ofFood Control Office, the local health departments, andBuffalo District brought Bon Vivant products distributed in upstate and western New York under control.County health departments cooperated in embargoingsmall lots of these products when found in distribution.These lots were then returned to wholesalers or weredestroyed. New York State or Federal seizures weremade at all distributors. The State seized 268 lots, ofwhich about 160 were in the New York City area.Federal authorities seized 18,179 cans of the soup.Some voluntary destructions of smaller lots have beenaccomplished and many more are anticipated in a concerted effort to assure that these questionable productsdo not get back into the channels of commerce.

CINCINNATI DISTRICT Homer R. Smith, Districtveterinarian, participated in the Farm Science Reviewat Columbus on September 21-23. He monitored anFDA exhibit on veterinary medicine and poison prevention that was part of the Review, which was sponsored by the Ohio State University and the Ohio Agricultural Research and Development Center.


DALLAS DISTRICT During September, the CampbellSoup Co., Paris, Texas, voluntarily recalled chickenvegetable soup after one day's production was foundto contain Clostridium botulinum toxin. In the subsequent follow-up investigation by Dallas District inspectors, one day's production of vegetarian vegetable soupfound to contain abnormal cans was voluntarily reca l l ed .

James Anderson, District chief inspector, and GeorgeHintgen, chief of the city of Dallas Environmental Control Service, were interviewed September 21 on a localradio program. After a brief discussion concerning thetype of work done by each agency, listeners telephonedthe station to ask questions concerning food anddrug matters—most of which were answered by Mr.A n d e r s o n .

KANSAS CITY DISTRICT The Metropolitan KansasCity Conference of Food and Drug Officials held itsfall meeting September 27 at the FDA District Building. Approximately 35 city, county. State, and Federalenforcement officials attended the day-long sessions atthe District building.

Featured speakers and their topics included RegionalFood and Drug Director Charles A. Armstrong—"Recent Developments in FDA"; Leon Hallberg, director of agri-business marketing. Vestal Labs, St.Louis, Missouri—"Training in the Marketplace"; andRandall lessee, director of the Division of PublicAffairs, Environmental Protection Agency, Region VI,Kansas City, Missouri—"EPA, What It Is and Does."

The morning sessions were devoted principally toopen discussions by the group on a number of areaproblems, including communication, agency responsibilities, work sharing, recalls and responsibilities. StopSales, etc. Serving as a panel of experts to answerquestions from the group were James A. Adamson,chief, FDA Special Programs Branch; Clarence Smythe,Kansas City, Kansas-Wyandotte County Health Department; Leonard L. Blanton, chief inspector, FDAKansas City District; and Dr. William Raithel, MissouriDivision of Health, Jefferson City, Missouri.

During the month of September, the District cited 11producers of beef cattle (8), swine (1), chickens (1),and turkeys (1) intended for human consumption. Themarketed animals and poultry contained illegal drugresidues in tissues analyzed by the U.S. Department ofAgriculture.

LOS ANGELES DISTRICT A variety of products wereeither seized or destroyed through FDA action in theDistrict during the month of September.

Protein powder labeled as an aid for weight reduction and as a source of amino acids was seized becauseof false and misleading claims for weight reduction andfor special nutritional qualities. Made from bulk materials that had moved in interstate commerce, the lot

of 95 cans had been packed for Arwin Co., LosAngeles, where seizure was made.

Because it was decomposed in part and had beenpacked under insanitary conditions, 4,681 cases ofBon Vivant canned soups was seized at five wholesalegroceries. Although decomposition was found in samples, no botulinus was detected. Seizures covered thedealers' entire stocks of this manufacturer's product,and one dealer voluntarily destroyed his stock of theproduct.

A lot of 1,897 100-pound bags of brazil nuts wasseized at a Los Angeles dealer because they containedinsects and mold. Also seized because of heavy insectinfestation was 704 boxes of comhusks.

Violation of the Fair Packaging and Labeling Actwith respect to quantity of contents statements resultedin seizure of five cosmetics and over-the-counter drugsin possession of a Los Angeles wholesaler. The products had been imported from England. Of the total,three were made by American firms in British plantsand were the same as their American-made productsexcept for violative labels.

A lot of 29,000 cases of candy mints and chewinggum containing cyclamates was voluntarily destroyedby a Los Angeles dealer. The lot had been manufactured by a San Francisco firm some time ago.

Elaine Roentgen, District consumer specialist, recentlyappeared on the Dinah Shore television show, discussing bacterial contamination of foods. Mrs. Roentgenrepresented Virginia Knauer on the NBC-TV program,"Agriculture USA," speaking on protection of thec o n s u m e r .

MINNEAPOLIS DISTRICT Severe difficulties seem tohave plagued the food industries recently—at least itappears that way from the FDA point of view in theDistrict area.

Because the product was found to contain Salmonellacontamination, a manufacturer of macaroni and eggnoodle products recalled and voluntarily destroyedmore than 188,000 pounds of egg noodles with awholesale value of $55,182. By replacing $17,000worth of equipment, the firm's management hopes tocorrect the problem and has indicated that no furthershipments will be made until laboratory analyses showall production to be free of Salmonella.

A corn-canning plant in Wisconsin operated forabout four weeks packing this year's corn crop withdefective can-seaming equipment, which resulted inextensive swelling of warehouse stock. Wisconsin Department of Agriculture authorities are cooperatingand have embargoed 145,000 cases of the pack.

Added to this are bona fide complaints of illnessesfrom consumption of canned corn, canned peas, and thefinding of a piece of rope in canned sauerkraut, as wellas 15,000 large cans of asparagus found to be undergoing decomposition with the cans bursting in thew a r e h o u s e .


NEW ORLEANS DISTRICT Universal Foods, RedStar Division, Belle Chase, Louisiana, is now experiencing difficulty in disposing of 150 tons of Salmonella-contaminated yeast accumulated under a recent recall.The Jefferson Parish Health Department estimated thedisposal cost to the company at one hundred dollarsper ton, due to possible environmental problems in thiscoastal area. The yeast is mostly in sealed two-poundc a n s .

The District detained over $309,392 worth of tunaduring September because of excess mercury, decomposition, and lack of compliance with FDA standards. Asa result of the west coast dock strike, a number ofwest coast importers were forced to use New Orleansas their port of entry, and canned tuna from Japanand Angola had arrived by the boatload.

Also detained during September were $776 worthof plastic toys with potential for accidental ingestionby children; $500 worth of decomposed olives; $31,500worth of decomposed canned tomatoes; $5,063 worthof insect-infested sesame seeds; $17,400 worth ofinsect-infested mung beans; $69,200 worth of mis-branded frozen shrimp; and $228 worth of illegalfireworks.

NEW YORK DISTRICT A problem that was broughtto New York District's attention recently now appearsto be under control. As a follow-up to an anonymouscomplaint forwarded to this District by FDA's LosAngeles District, New York District inspectors learnedthat Modern Maid Food Products, Jamaica, had produced 120,000 pounds of breading material contaminated with small pieces of rubber gasket that had beenintroduced into the grinding/sifting equipment. Theproblem had been discovered by a U.S. Departmentof Commerce fishery products inspector after 5,000pounds of breading material had been used to breadfish at Icelandic Products, Camp Hill, Pennsylvania.The contaminated fish were placed under CommerceDepartment quarantine and the remaining 115,000pounds of breading material was returned to ModernMaid, where it is currently being sold for pig feed. District inspection had revealed that the problem waslimited to the 120,000 pounds of breading materialmade for Icelandic Products.

In checking further. New York District found thatthe Los Angeles informant had learned of the problemfrom reading Commerce Department memos that weresent to their field inspectors alerting them to thiss i tua t ion .

The cooperative FDA/American Can Company boothat the New Jersey State Fair was one of the more popular booths there, it appeared. It was not unusual tosee viewers crowded around the booth four and fiverows deep. In the first four days, despite inclementweather, an estimated 15,000 to 20,000 visitors wereattracted to the exhibit. FDA inspectors manning it

reported that it was particularly gratifying to experiencethe interest and concern of the fairgoers, who commented on the abnormal cans exhibited and on foodsafety in general.

PHILADELPHIA DISTRICT District representativesparticipated in two workshops held in Philadelphia inSeptember. On September 23 Loren Johnson, DRFDD;Francis J. Fiskett, food and drug officer; and Wards-worth Gray; along with Dale Miller and Richard Earlyof the Bureau of Product Safety, Washington, took partin a workshop on hazardous substances. The seminar,attended by approximately 150 industry representatives, was sponsored by the National Paint, Varnishand Lacquer Association.

On September 22-24, Region III and the FDATraining Institute cooperated in conducting a workshopfor local and State health officials, entitled "CurrentConcepts in Food Protection." This course was basically confined to regulatory aspects of food serving andhandling, and was sponsored by the Philadelphia Department of Health. Attending this workshop were63 sanitarians, representing the city and State departments of health, including those in New Jersey,Pennsylvania, and the Territory of Guam.Drug officials from two foreign countries visited theDistrict recently. Dr. T. N. Bhan and A. Chakravartifrom India ended a four-week visit September 3. Theyhad visited 13 different drug manufacturers with theDistrict inspectors during their stay, observing andlearning manufacturing procedures.

Drs. Peter Fischer, Max Sahli, and T. Witschi, aSwiss delegation, began their visit to the District onSeptember 14. They visited two of this Nation's majordrug producers with District food and drug inspectorsand observed the production of all types of dosage-form drugs. They were particularly interested in qualitycontrol systems, high-speed production, and inspec-tional techniques.

SAN FRANCISCD DISTRICT The largest seizure foreconomic violations in recent District history occurredSeptember 13, when a U.S. marshal took into custody33,000 pounds of cheese, charged to be totally lackingin any kind of labeling.

Because of subpotency, the District also orderedseizure September 22 of 7,400 vials of progesteroneinjection in oil. The product, seized in possession of amanufacturer in the San Francisco area, had beenmanufactured from raw materials received in interstatec o m m e r c e .

The District's seizure in September of four lots ofBon Vivant soups held by local distributors amountedto a total value of approximately $24,000. The products were alleged to have been processed under conditions whereby they may have become contaminatedwith filth or whereby they may have been renderedinjurious to health.


The Fourth International Containerization Expositionand Technical Congress was held at the OaklandColiseum from September 13 to 17. The District participated with headquarters personnel in preparing anFDA exhibit booth for the Exposition that was designed to portray the Agency's import inspections mission and to reflect changes in our procedures in recognition of containerization as a new concept in thehandling of imported commodities. In preparation forthe exhibit, San Francisco District personnel prepareda three-fold brochure entitled "Imports and FDA" portraying FDA's import obligation. This is the firsthandout of its kind ever designed solely to tell the FDAimport inspections story.

SEATTLE DISTRICT American Freezerships, Kodiak,Alaska, has ceased production for the present as aresult of a joint FDA-Alaska State inspection. Thefirm, housed in a converted ferry boat, was found tobe packing shrimp meat under insanitary conditions,which led to State seizure of more than 70,000 poundsof the product on September 29. Alaska State officialshave indicated that future production will be prohibitedu n t i l a l l v i o l a t i v e c o n d i t i o n s h a v e b e e n c o r r e c t e d . T h e

shrimp meat never left the State, but it had been offeredf o r i n t r o d u c t i o n i n t o i n t e r s t a t e c o m m e r c e .

FOOD AND DRUG ADMINISTRATION DISTRICTS

U.S. District Court Judge William Beeks ruled inSeattle on September 15 that a Relaxacizor deviceshipped to Hollywood, California, in 1970 by a Seattlewoman would not be returned to her. After the devicearrived in California, FDA had sampled and seized it.The judge in ruling on the case said, "The device isinherently a very dangerous product, and there is nomethod by which its use may be rendered safe." Hethen ordered the Relaxacizor destroyed.

F D A D I S T R I C T O F F I C E S H E W R E G I O N A L O F F I C E S l - X

ATLANTA 60 Eighth St., N.E.A t l a n t a , G a . 3 0 3 0 9

B A LT I M O R E 9 0 0 M a d i s o n A v e .B a l t i m o r e , M d . 2 1 2 0 1

B O S TO N 5 8 5 C o m m e r c i a l S t .B o s t o n , M a s s . 0 2 1 0 9

B U F FA L O 5 9 9 D e l a w a r e Av e .B u f f a l o , N . Y. 1 4 2 0 2

CHICAGO Main Post Office BIdg.R m . 1 2 2 2 4 3 3 W. Va n B u r e n S t .

Chicago, III. 60607CINCINNATI 1141 Central Pkwy.C i n c i n n a t i , O h i o 4 5 2 0 2

DALLAS 3032 Bryan St.D a l l a s , Te x . 7 5 2 0 4

DENVER New Customhouse BIdg.R m . 5 6 0 4 / 2 0 t h & C a l i f o r n i a S t s .D e n v e r , C o l o . 8 0 2 0 2

DETROIT 1560 E. Je f fe rson Ave.D e t r o i t , M i c h . 4 8 2 0 7

KANSAS CITY 1009 Cherry St.Kansas City, Mo. 64106

LOS ANGELES 1521 W. P ico B lvd.Los Angeies, Caiif. 90015

MINNEAPOLIS 240 Hennepin Ave.Minneapolis, Minn. 55401N E W O R L E A N S U . S . C u s t o m h o u s eR m . 2 2 2 / 4 2 3 C a n a l S t .N e w O r l e a n s , L a . 7 0 1 3 0

NEW YORK 850 3rd Ave. (at 30th St.)Rm. 700/Brooklyn, N.Y. 11232

P H I L A D E L P H I A U . S . C u s t o m h o u s eR m . 1 2 0 4 / 2 n d & C h e s t n u t S t s .

Philadelphia, Pa. 19106SAN FRANCISCO Federal Office BIdg.R m . 5 1 8 / 5 0 F u l t o n S t .San Francisco, Calif. 94102

SEATTLE Federal Office BIdg.R m . 5 0 0 3 / 9 0 9 F i r s t A v e .S e a t t l e , Wa s h . 9 8 1 0 4

BOSTON J. F. Kennedy Federal BIdg.B o s t o n , M a s s . 0 2 2 0 3NEW YORK 26 Fede ra l P lazaN e w Yo r k , N . Y. 1 0 0 0 7

P H I L A D E L P H I A 4 0 1 N o r t h B r o a d S t .Philadelphia, Pa. 19108ATLANTA 50 7th St., N.E.R m . 4 0 4 / A t l a n t a , G a . 3 0 3 2 3

CHICAGO New Post Office BIdg.433 W. Van Buren St./Chicago, III. 60607KANSAS CITY 601 E. 12th St .Kansas City, Mo. 64106D A L L A S 111 4 C o m m e r c e S t .R m . 9 11 / D a l l a s , Te x . 7 5 2 0 2

DENVER Federal Office BIdg.19th & Stout Sts./Denver, Colo. 80202SAN FRANCISCO Federal Office BIdg.R m . 4 1 6 / 5 0 F u l t o n S t .S a n F r a n c i s c o , C a l i f . 9 4 1 0 2

SEATTLE Arcade Plaza BIdg.1 3 2 1 2 n d Av e . , S e a t t l e , Wa s h . 9 8 1 0 1


INJURIES ASSOCIATEDWITH SNOWBLOWERSSnowblowers can eliminate much of the drudgery ofshoveling snowy walks and drives, but they can alsohave unexpected potentialities for serious injuries,according to the Bureau of Product Safety.

During the past several years, FDA's Injury StudyUnits in Boston and Denver have conducted 57comprehensive investigations of snowblower accidents.These studies show that injuries from snowblowerscan be severe. However, good power mower practicescan be adapted for operating snowblowers for aneffective, year-round safety program.

Snowblowers and power lawn mowers are similarin that both are machines with rotating parts. Theyeject semifluid material as they are steered alon^g apath. Snowblowers differ in that a typical machine hasa spiraling auger to cut into icy, hard-packed snow.This material is then ejected through a chute, whichcan clog, particularly after heavy, wet snowfalls. In33 of 57 cases, according to John Locke, chief ofthe Injury Study Unit, wet snow was an environmentalf a c t o r .

Studies show that householders are the mostfrequent owners and operators for both power lawnmowers and snowblowers. However, the moweroperator has several factors contributing to hisadvantage. He can become proficient in handling themower during frequent use in long summer months ashe combats the rapid growth of well-tended lawns.He has time on his side, for he can wait until thegrass is dry and the children are out of the yard. Hisclothing is light-weight and at a minimum. For bodyprotection, he needs only sturdy work shoes andsomething to screen the sun's rays to avoid sunburn.His path is generally clear of obstacles to himself andh i s m a c h i n e .

The situation changes drastically for the harriedhouseholder using a snowblower to clear driveway andwalks of last night's heavy snowfall. Often he has adeadline for getting the job done. He has to clearthe driveway quickly to get his car out, for he is duea t t h e o f fi c e . H i s c h i l d r e n w i l l b e l a t e f o r s c h o o l . A n dhis wife must make a meeting on time. He knows thathe should clear sidewalks as promptly as possibleto avoid injuries from falls to family members orpassers-by with the resulting legal liabilities.

However, his work is often difficult, for he must workwith slippery, uncertain footing from the snow itselfand possibly ice beneath. He is bundled up in warm

but cumbersome clothing, including mittens that hindermanipulation of handles and switches and can becomecaught in the machine's moving parts. His heavyscarf and cap can obscure his vision, as can the vaporsof his frosty breath.

Because it snows only occasionally in manycommunities where snowblowers are used, the ownermay be unfamiliar with his snowblower. He findshis cold machine difficult to start in the cold air. Andonce it's started, he is reluctant to turn off the machinefor any reason. He isn't expert with the machine'sc o n t r o l s .

When snow clogs the ejection chute, too frequentlyhe has reached in with a gloved or mittened hand toclear away the snow, regardless of the whirling bladeshidden by the hard-packed snow. Studies by theBoston Injury Study Unit show that 67 percent ofthe victims investigated were injured in this manner,and 95 percent of these suffered damage to the hands.(The accompanying chart shows the percentage ofhand injuries in relationship to the total number ofinjuries investigated, as well as the preponderance ofinjuries occurring in discharge chutes.)

The same studies showed that human errors werethe major factors in the cases investigated. Operatorsfailed to take precautions in clearing dischargechutes. More than half of the victims had done thesame thing several times previously and escaped injury.In almost half the cases, the operator was using themachine for the very first time or for the first timethat season. Since more than half (65 percent)of the accidents studied in Boston and Denveroccurred within the first hour of operation, fatiguewas probably not an important contributing factor.

Also, work habits contributed further hazards.Records showed that injuries occurred when operatorsworked in front of machines or slipped on icysurfaces or both. As a result, a hand was struck bythe impeller blades or auger. Other human factorswere shown to be failure to disengage the blower'sblades, failure to shut off the engine, and failure towait for blades to stop rotating before attemptingto clear the discharge chute.

The studies included two types of snowblower design:The single-stage machine has a large auger in

front, which cuts into snow and then ejects it througha discharge chute by means of an auger flange. Thisflange is usually located in the middle of thespiral-shaped auger, and snow is drawn into it asthe auger rotates. For ejection of the snow efficiently,the auger must rotate rapidly.

A two-stage machine has, in addition to the


S n o w b l o w e rA c c i d e n t s *

Clearing Clogged Chutes6 6 . 7 %

1 0 % 2 0 % 3 0 % 4 0 % 5 0 % 6 0 % 7 0 % 8 0 % 9 0 % 1 0 0 %

A l l O t h e r A c t s

3 3 . 3 %

snow-cutting auger, a separate impeller at the base ofthe discharge chute. Although the auger of this type ofmachine turns more slowly, the impeller rotates at ahigh speed to eject the snow from the chute.

Some makes of snowblowers have a mechanismwhereby the auger or impeller or both can be disengagedwithout shutting off the engine. Other machines haveno such mechanism and the engine must be shut off tohal t the ro ta t ion of the b lades.

Most, if not all, of today's self-propelled models wereshown to have either a gear shift, which can be movedto a neutral position, or a "dead man's" control, therelease of which stops the machine's forward motion.With neither type, however, is the auger's or impeller'srotation stopped.

The most common type of chute guard was shown tobe a piece of heavy-gauge wire in the shape of an"M." Another type of guard is flexible plastic in apaddle shape, which partially covers the chute openingand bends outward as snow is ejected. Majordisadvantages of both types are that they maycontribute to chute clogging, and the wire guard iseasily removed.

Of the cases investigated, 65 percent of the machinesinvolved had accompanying warnings, but these didnot seem to be effective in preventing accidents. Suchwarnings included: "Stay clear of chute outlet whenengine running," "Caution—stop engine beforeremoving foreign objects from blower or rake,""Don't put hands or feet near auger when turning," and"Keep hands out of chute with motor running."

The Bureau of Product Safety makes several safetyrecommendations. The two most importantrecommendations for accident prevention would bechanges in equipment design that would reduce thecommon tendency for chutes to clog or that wouldpermit safe removal of clogged snow. To the extentpossible, these changes should be so developed thatthey could be fitted to machines now in use as well.

Further recommendations include a "dead man's"

control in a snowblower's handle that would not onlystop the machine's forward motion but would also haltthe rotation of impeller blades or auger.

The Bureau recommends that new operators be giventhorough instructions and a short training session inproper snowblower use at time of purchase.Instructions should show specifically the hazardousaspects and practices as found in the Boston andDenver studies. The purchaser should be shown exactlyhow to clear a clogged discharge chute safely.

The Bureau's safety recommendations forsnowblower operators include the following. (Many ofthese tips can be adapted to power lawn mowers.)

1. Disconnect the engine and wait until blades stopmoving before trying to clear the discharge chute.

2. Don't try to hurry, especially when the worksurface is wet or slippery. Melting ice provides slick,treacherous footing—a hazard often involved ins n o w b l o w e r a c c i d e n t s .

3 . Don ' t l eave a snowb lowe r un tended f o r a momen t .

Stop the motor completely when you leave.4. Don't work while wearing soft footwear. Wear

sturdy work shoes and heavy, close-fitting slacks toprotect feet, ankles, and legs.

5. At the beginning of each winter season, re-readmanufacturer's instructions for the machine's safetya n d m a i n t e n a n c e .

6. Know and practice using the machine's controlsso in an emergency you'll do the right thingautomatically. Be sure you know how to stop the motorin an ins tan t .

7. Be sure that only competent, well-trained personsoperate the machine.

8. If possible, clear the work area of stones, wire,toys, and other debris before the job is started. Watchfor anything that could be forcibly ejected through thedischarge chute.

9. Know where children and pets are while youwork. Keep them at a safe distance. Remember, this isnot a spectator sport!



P u b l i c Wa r n e d o f R a d i a t i o n R i s kFrom Faulty Microwave Oven Model

FDA reported on October 1 that the RR-1 modelof an Amana microwave oven has the potential of beingoperated with the door open, thus exposing users todangerous levels of microwave radiation.

Four units of the RR-1 Amana Radarange manufactured by Amana Refrigeration, Inc., Amana, Iowa,have been found with defective safety interlockswitches. Safety interlock switches are a safety featuredesigned to prevent operation of the units when thedoor is open. Exposure to microwave radiation fromthe open door could cause severe burns, eye cataracts,or other damaging effects.

FDA urged all owners of the RR-1 ovens to unplugthe unit, call a local Amana service representative or theAmana Company, and refrain from using until serviced.

The company produced 5,400 of these models fromSeptember 1967 to October 196.8. The model RR-1oven is a portable unit which can be distinguished fromlater models by its two push buttons for oven operation.Later models have three push buttons.

FDA Proposes Child-Proof PackagingFor Wintergreen Oil, Drugs of Abuse

The FDA has proposed to require "child-resistant"packaging for liniments and other liquid preparationscontaining more than 5 percent of methyl salicylate(oil of wintergreen) and for those drugs subject tocontrols under the Comprehensive Drug Abuse Prevention and Control Act .of 1970. The proposal concerning products containing methyl salicylate was published in the Federal Register of September 29 andthat concerning drugs of abuse in the Federal Registero f O c t o b e r 1 5 .

Charles C. Edwards, M.D., Commissioner of Foodand Drugs, said injury reports to FDA's Bureau ofProduct Safety and other Government agencies showthat 176 accidental ingestions of methyl salicylate bychildren under five years of age occurred in a 3-yearperiod, 1968 through 1970. Of these, 33 children werehospitalized and eight died.

"This product is attractive to children because of itswintergreen odor," Dr. Edwards said. "As little as oneteaspoon of methyl salicylate has been reported to bef a t a l . "

The special packaging would be designed so thatnot more than 2 milliliters (less than half a teaspoon)wil l flow from the container when it is inverted andshaken or squeezed once. Also, the standard would

require that 85 percent of a test group of 200 children(ages 42 to 51 months) be unable to open the container and that 80 percent fail after a demonstration ofhow to open it. Of a test group of 100 adults, 90 percent must be able to open and close the container.

The proposed regulations were reviewed by thePoison Prevention Packaging Act Technical AdvisoryC o m m i t t e e .

The proposal to require "child-resistant" packagingfor drugs subject to controls under the ComprehensiveDrug Abuse Prevention and Control Act of 1970covers approximately 4,300 drugs listed under the Act.Controlled drugs are defined by the law as those thathave been determined by the Attorney General to havea potential for abuse.

Dr. Edwards, in announcing the FDA move, saidthe proposed packaging regulations are designed especially to protect children under the age of five fromaccidental ingestion of narcotic, depressant, and stimulant drugs used in the home.

Reports to FDA's National Clearinghouse on PoisonControl during 1970 concerning accidental ingestionsby children under five show 945 ingestions and 108hospitalizations from amphetamine-type products; 437ingestions and 73 hospitalizations from barbituratesedative products; and 10 ingestions and 5 hospitalizations from methadone, a drug used in the treathient ofh e r o i n a d d i c t i o n .

The proposed standards for closures on controlleddrugs would require the same difficulty for opening asthose for the oil of wintergreen products.

Industry Cooperation Urged in StudyO f M a t e r i a l s L i s t e d G R A S i n P a s t

Manufacturers, formulators, and other users of foodadditives were urged by the FDA to cooperate in asurvey to determine the levels of use of materials thathave in the past been considered GRAS (GenerallyRecognized As Safe).

Charles C. Edwards, M.D., Commissioner of Foodand Drugs, in announcing the survey October 19, saidit is part of an overall review by FDA to determinewhat materials can qualify for listing as GRAS andwhat materials will be approved for food additive useonly on the basis of individual review and regulation.The survey is being conducted for FDA by the NationalAcademy of Sciences.

Quest ionnaires have been distr ibuted to manufacturers, formulators, and other users of the substancesthrough direct contact, various trade associations, andother methods. To provide the broadest possible basis


for making determinations about the toxicity of thesubstances, FDA is particularly anxious to reach smallusers and those who may not be affiliated with tradeassociations.

The specific substances about which FDA needs information are, in addition to those on the GRAS list,those sanctioned through FDA action, meat inspectionaction, or poultry products inspection action, prior topassage of the Food Additives Amendment of 1958.

Commissioner Edwards stressed that although obtaining and filling out the questionnaires is purely voluntary, it is important that all users of the substanceshave an opportunity to participate in the survey intendedto help in reaching decisions about the toxicity datanecessary to support continued safe use of suchsubstances.

Anyone not yet contacted who wants to cooperatecan obtain a questionnaire from the Subcommittee onGRAS Review, Food Protection Committee, NationalAcademy of Sciences-National Research Council, 2101Constitution Ave., N.W., Washington, D. C. 20037,attention Durwood Dodgen. If more convenient, Mr.Dodgen can be contacted by telephone at (202)9 6 1 - 1 5 3 7 .

New FDA Policy Tightens RegulationOf Fixed Combo Prescription Drugs

FDA has made final a proposed Agency requirementthat prescription drugs composed of more than oneingredient combined in fixed dosage form (a pill, capsule, teaspoonful) offer the patient a therapeutic advantage over any of the components administeredseparately.

The new policy, which became effective October 14,affects up to 40 percent of widely sold prescriptiondrugs. Over-the-counter drugs—those sold without prescription—will be dealt with separately.

The new FDA policy on fixed combination prescription drugs:

(A) Two or more drugs may be combined in asingle dose form when each contributes to the claimedeffects. The dosage of each ingredient (amount, frequency, duration) must be safe and effective for asignificant number of patients who require concurrenttherapy with the drugs. Special cases of this generalrule are where an ingredient is added to:

• enhance the safety or effectiveness of the principal ingredient; or

• rninimize the potential for abuse of the principalingredient.

(B) If a combination drug presently licensed ischanged to meet new requirements based on a reviewfor effectiveness by the National Academy of Sciences-National Research Council, then formulation, labeling,or dosage changes may be proposed and any resultingformulation may meet the basic requirement listedabove.

(C) Any fixed combination drug for humans judged

effective by FDA based on evaluation of the NAS-NRCreports meets the requirements of the policy.

FDA proposed the policy on fixed combination drugson February 18, 1971. The Agency received more than1,000 letters from physicians and comments from medical and pharmaceutical groups. Apparently the proposal was not completely clear.

The final statement has been simplified. The primarychange is the removal of over-the-counter (OTC) drugsfrom the provisions of the proposed policy statement.

There was strong opposition to judging OTC drugs bythe same criteria used for prescription drugs. FDAagrees that the differences in the two classes of drugswarrant separating the OTC drugs for separate cons i d e r a t i o n .

In addition the requirement that the combinationdrugs be useful for "most" patients for whom it wouldbe prescribed has been changed to a "significant number," as defined in the labeling for the drug.

Basically the policy proposed in February 1971 isunchanged. The revisions state the requirements morebroadly with the intention that they will provide auseful guide to industry in considering introduction offuture combination products.

The policy statement, published in the October 15Federal Register, provides a clearer and more flexibleamplification of FDA policy on prescription drugs infi x e d c o m b i n a t i o n s .

FDA Begins Inventory of All DrugsCurrently Marketed for Human Use

FDA is initiating an inventory of all drugs marketedfor human use in the United States, the Agency announced October 7. The drug industry will be askedto supply information voluntarily covering all prescription and nonprescription drugs, vitamins, anda n t i b i o t i c s .

"The objective," said Charles C. Edwards., M.D.,Commissioner of Food and Drugs, "is to obtain complete information on all finished dosage forms of drugscurrently marketed for human use." Much of this information is not now available to the Agency.

Legislation requiring mandatorv registration of alldrugs is being considered by the Congress. This legislation would require the industry to submit inventoryinformation routinely starting December 31, 1972.

"In the interim," said Dr. Edwards, "we believethat much can be gained by seeking voluntary industrycooperation in providing the much needed information."

Between October 15 and November 1, 1971, reportforms were to be sent out in preparation for the voluntary inventory. FDA officials scheduled a series ofbriefing sessions for industry in major cities betweenthose dates to explain the purpose, scope, and detailsof the inventory.

The survey includes information on production, formulas, coding, and labeling all drugs for human usethat are subject to the Food, Drug, and Cosmetic Act.


state act ions

Frozen Dessert Change The Pennsylvania Department of Agriculturehas announced that a public hearinghas been set for taking testimony ona proposed change in the Pennsylvan ia F rozen Desser ts Law. Thechange would allow greater use oflocally produced dairy products.

Changing the regulation to include cheese whey, a byproduct ofthe manufacture of cottage cheese,could make the product more profitable to the local dairy industry.

The hearing has been scheduledfor Wednesday, January 5, 1972, at10 a.m., in Room 309, Departmentof Agriculture Building, Harrisburg.

Oregon to be Host State of Oregonrepresentatives planned to be hostfor a Milk Sanitation Rating OfficersSeminar to be held November 3-5 atthe State Office Building in Portland. Milk sanitarians and inspectors for the States of Alaska,Washington, Idaho, and Oregon willattend the seminar set up by RegionX of the Food and Drug Administration, Public Health Service.

Vergil Simmons, assistant administrator for milk and dairy products.Dairy and Consumer Services Division, Oregon Department of Agriculture, is in charge of the State'sarrangements and will also be chairman of the first day's session. Kenneth E. Carl, administrator. Dairyand Consumer Services Division,will welcome those attending theseminar. William G. Kupp, Seattle,chief of the special programsbranch. Region X, FDA, will opent h e s e s s i o n s w i t h a d i s c u s s i o n o faims and purposes of the seminar.

Also participating in the programwill be three top FDA people fromthe East: Harold Thompson, Washington, chief of the Milk SanitationBranch, Div is ion of Food Serv iceand Milk Sanitation, Bureau ofFoods; Milt Gates, Washington,ass is tan t t o the d i rec to r o f t he D iv ision of Regulation Guidance, Office

of Compliance, Bureau of Foods;and Dr. John Messer of the laboratory development program of theFDA Research Laboratories, Bureau of Foods, Cincinnati, Ohio.

Also included on the program areto be the following Oregon men:Dr. Edward Press, State health officer, Oregon State Board of Health;Doug Pike, assistant director. Department of Local Health Services,Oregon State Board of Health;Floyd Bodyfelt, dairy extensionspecialist. Department of FoodTechnology, Oregon State University; and A1 Tesdal, milk sanitarian,Oregon Department of Agriculture.

New City Program Henry Etche-mendy, city manager, Carson City,Nevada, recently approved and announced the adoption of a programto motivate the enhancement of foodservice sanitation standards in Carson City restaurants. He said theprogram will be put into effect andmanaged by F. J. Picard, director.Environmental Health Services, Carson City Health Department.

Following the announcement, Mr.Picard said, "This is only a logicalfollow-up to the newly introducedcontinuing education program initiated at the Sanitation Seminar heldearl ier this month. The restaurantoperators' demonstrated enthusiasmtoward achieving the highest sanitation standards in the State compelledthe inception of a program such asthat being introduced." Mr. Picardcontinued, "The program is anatural extension of the progressiveattitude of the governing body ofthis community. This is only one ofmany activities that reflects the concern of this city's elected and appointed officials for the welfare ofr e s i d e n t s a n d v i s i t o r s . "

Beginning in January 1972, foods e r v i c e e s t a b l i s h m e n t s w i l l b egrouped, for award eligibility purposes, into three categories. Thoserestaurants maintaining a competi

tively low, inspection-revealed, violation rate over a period of sixmonths will be eligible for the"Superior Sanitation Award." Theaward may be displayed in the establishment for the ensuing six-month period at which time it willbe reawarded or surrendered depending upon eligibility status atthat time. When displayed, the certificate will be evidence of responsible management and employee effort to provide the safest, mostwholesome food possible to the establishment's patrons.

Aid for Consumers Motivated notonly by increasing consumer complaints but by the once frequendyused term, "It just made me seered!" Jane Wyatt, consumer officerof the Oregon Department of Agriculture, has prepared a consumerpamphlet just to suit this mood ofred. Its cover is a deep bright pink,seeming to reflect the mood of anirate consumer. Entitled, "Do YouHave a Complaint . . . ," the pamphlet tells a consumer how to prot e c t h e r s e l f .

Although "seeing red" has beensupplanted by more modern termsfor describing one's state of anger,there are times when this phraseconveys the most accurate pictureof a consumer's feelings—when apurchase she has made turns out tobe inferior to what it appeared to bein the store. This is particularly trueof a food around which a menu hasbeen planned and the consumer isforced to use it and make the bestof it, or if it is a case of being short-weighted to the point that servingshave to be reduced in size.

Mrs. Wyatt notes that one of thestatutory functions of the OregonState Department of Agriculture isto assure the consumers of the Statea safe, wholesome food supply,properly packaged and labeled. Sheadvises the consumer who has aproblem with food articles to con-


tact the firm or individual involvedto try to work out an adjustment,and to keep notes of all transactionsand copies of receipts, letters, etc.Should the consumer fail with thisapproach, Mrs. Wyatt says, the nextstep she may want to take is aformal complaint. In the case offood products, the agency to contact is the Oregon Department ofAgriculture.

To make it easy for the consumerto file this complaint, there is aconsumer complaint report form onthe back page of the new pamphlet.

Board of Health Survey The Alabama S ta te Boa rd o f Hea l th i s con

ducting a survey to determine theadequacy of individual waste disposal facilities of all oyster processing plants. The work is being carriedout by local health department sanitarians with special attention to disposal practices for human wastes.As of September 1, no plants hadb e e n c e r t i fi e d f o r i n c l u s i o n o n t h eInterstate Shellfish Shippers list.One of the main purposes of thisState survey is to document the needfor a sewage treatment plant inBayou La Batre.

Department Levies Penalties TheNew York State Department ofAgriculture and Markets leviedpenalties against 177 firms and persons during August for alleged violations of the State Agriculture andM a r k e t s l a w. A n a d d i t i o n a l 1 0 6cases were referred to the AttorneyGeneral for disposition. A meatpacking firm in Jamaica was assessed the top penalty of a thousanddollars for cutting beef without Stateinspection.

Botulism Report Representativesof the Ohio Department of Healthand A. J. Earney, Holmes CountyHealth Commissioner, report that aHolmes County family recently hada narrow escape from disaster. Because the contents of two quart jarsof home canned com did not looknor smell right, the family fed thecorn to their hogs. Ten pigs died.Other jars of the corn were discarded, resulting in the death ofchickens, another pig, and a hog.

The family called in a veterinarianwho diagnosed the deaths as due tob o t u l i s m . H e s e n t s o m e o f t h e c o mto the Ohio State Health Department, where botulism toxin type Bw a s i d e n t i fi e d .

Cooperative Workshops The IowaDepartment of Agriculture, IowaGrain and Feed Association, andIowa State University sponsored aseries of Feed Mil l OperationsWorkshops throughout the State theweek of September 13. At least 300feed mill operators and employeesattended the evening sessions heldat Des Moines , Wi l l iamsburg ,Waterloo, and Storm Lake.

The program presented was designed primarily to assist and explain the responsibilities of thosepersons involved in the feed milland delivery operations. Featuredspeakers included Dr. Robert A.Wilcox and Extension SpecialistJames L. Balding, of the FormulaFeeds Division, Kansas State University, Manhattan, Kansas; and Dr.C. Phillip Baumel, research professor, Iowa State University, Ames,Iowa. The Kansas team of specialists has put on similar programs forfeed mill operators and employeesin that State for the past severaly e a r s .

Consumer Complaints A consumercomplaint to the Kansas City, Missouri, Health Department on September 9 conceming hamburgermeat brought about immediate conviction of a local meat cutter andcondemna t ion and des t ruc t i on o f380 pounds of adulterated hamburger. Also detained by the CityHealth Department was approximately 30 pounds of "XXX Washing Powder," which was used as theadu l te ran t and con ta ined sod iums u l fi t e .

Robert Smith, meat cutter at theHen House Super Market chargedwith selling the adulterated meat,was found guilty in municipal courtand sentenced to 30 days in jail. Thesentence was suspended and the defendant was placed on probation fort w o y e a r s .

Dr. Edwin O. Wicks, city healthdirector, said laboratory analysis re

vealed excessive amounts of sodiumsulfite in the hamburger. This substance retards decomposition, masksthe taste and odor of putrid meat,and gives the meat red color thatfalsely makes it appear to be fresh.

Pennsylvania Embargoes JohnTimo, a Pennsylvania State Department of Health inspector, embargoed and seized eight Relax N'Trim kits September 1 in possessionof a Seward, Pennsylvania, dealer.The kits, sold as a reducing treatment, were deemed misbranded dueto lack of mandatory labeling andbecause of inadequate directions foruse. They had been shipped byRelax N' Trim, West Los Angeles,Cal i forn ia . The State se izure wasupheld by State court at a hearingheld September 10, and the lot wasordered destroyed or relabeled tocomply with State law.

During the week of September 20,Mr. Timo placed under State embargo a lot of Crataegus digitalisstrophanthus compound manufactured by the Zemmer Company,Oakmont. State charges were basedon misbranding because of inadequate directions for use. The lot wasvoluntarily destroyed by the firmand the product dropped from itsl i n e .

California Restrains A fruit canningfirm in Dinuba, California, and allof its officials were temporarily restrained recently by the State ofCalifornia from further packing offruit in its plant because of insanitary conditions. A hearing for apermanent injunction was held October 1, at which time the courttemporarily enjoined the firm for atwo-week period. This time wasallotted to the firm to clean up andotherwise meet State requirements.At the end of the two-week period,o r a t a t i m e w h e n t h e fi r m f e l t i twas ready, a joint inspection was tohave been made by a CaliforniaState food and drug inspector andan inspector from the U.S. Department of Agriculture. The inspectorswere then to report to the State Attorney General for further decisionby the court as to the permanencyof the injunction.


s 1 i

•

SEIZURE ACTIONS charging violation of the Federal Food, Drug, and Cosmetic Act and the Federal Hazardous Substances Act are published when they are reported by the FDA District Office.

A total of 44 actions to remove from the consumer market products charged to be violative were reported in September. These included 28 seizures of foods: 3 involved charges concerning poisonous and deleterious substances, 18 involved

charges concerning contamination, and 7 involved charges concerning economic and labeling violations. Other seizures included 1 of vitamins and dietary food, 2 of drugs, 1 of cosmetics, and 12 of hazardous substances.

PRODUCT, PLACE & DATE SEIZED

Catfish food/Guntersville, Ala. 8/19/71

Montgomery, Ala. 8/ 19/71 Trout chow/Lumber City, Ga. 8/24/71

Alaskan razor clams/ Everett, Wash. 8/25-27 /71

Cocoa beans/Camden, N.J. 7/28/71 Flour, all purpose, USDA Consumer Market

ing Service/Chicago,. Ill. 9/3/71 Shrimp, frozen/New Orleans, La. 9/3/71

St. Cloud, Minn. 7 /8/71

Soups, Bon Vivant/Bristow, Okla. 9/2/71

New Bedford, Mass. 9/10/71 Charlestown, Mass. 9/8/71 Amesbury, Mass. 9/ 8/71 Long Island City, N.Y. 9/ 13/71 San Antonio, Tex. 9/3/71 Dundee, Ill. 9/7/71 Rolling Meadows, Ill. 9/7/71 Indianapolis, Ind. 9/10/71

Soups, canned, "Bon Vivan!," "Chelten," "Slim-Ette," "Slimline," and "Ancora" brands/Rochester, N.Y. 9/13/71 "Bon Vivan!" and "Ancora" brands/

Lansdowne, Md. 9 /7 /71 Tomatoes, canned/ Proctor, Okla. 7 / 2/71

Cherries, canned/Tipton, Ind. 9/ 8/ 71

Dot pork sausage seasoning/ Houston, tex. 8/3/71

Fish bal Is, canned, gooseberries, canned, Hawaiian cocoanut snow, Maggi Swiss style dumplings, sweet pickled apricots/ Salt Lake City, Utah 9/9/71

Lime juice, mangoes/ Brooklyn, N.Y. 8/30/71

Sour cream/ Little Rock, Ark. 7 / 23 / 71

Strawberry yogurt, lemon yogurt/Houston, Tex. 7/19/71

Veron quince jam/ Chicago, 111. 8/ 5/71

36 I November 1971 I FDA Papers

MANUFACTURER (M}, PACKER (P), SHIPPER (SJ, DEALER (DJ

CHARGES

FOOD/Poisonous and Deleterious Substances

Ralston Purina Co./Memphis, Tenn. (M,S) Contains a polychlorinated biphenyl compound, which may render it injurious to health.

"

Ralston Purina Co./St. Louis, Mo. (M,Sl

Contamination, Spoilage, Insanitary Handling

Certified Alaska Clams/ Kodiak, Alaska (P,Sl

Imported from Ecuador. Unknown. Shipped from Wisconsin.

Shell Fish Imports/ Miami, Fla. (SJ Tupman Thurlow Co., lnc./New York, N.Y.

(Distributor) Imported from India Bon Vivant Soups, lnc./Newark, N.J. (M,S)

Bon Vivan! Soups, lnc./Newark, N.J. (M,S) and Penn Foods, lnc./Philadelphia, Pa. (S)

Bon Vivant Soups, lnc./Newark, N.J. (M,S) and S.S. Pierce Co./ Boston, Mass. (S)

Proctor Canning Co./ Proctor, Okla. (D)

Prepared and packed under insanitary conditions.

Insect damaged, decomposed, moldy. Held in rodent-infested railcar.

Partly decomposed. "

Prepared under insanitary conditions; defective and abnormal cans.

Prepared under insanitary conditions; defective and abnormal cans.

Partly decomposed.

Economic and Labeling Violations

Stokley Van Camp, Inc./ Hart, Mich. (M,Sl

Dottley's Spice Mart, lnc./McGhee, Ark. (M,S)

Imported from various countries. Holly World Foods, lnc./San Francisco, Calif. (S)

Imported from the West Indies. Lou Scharf, lnc./New York, N.Y. (Distributor)

Mid-America Dairymen, I nc./Springfield, Mo. (M,S)

Mid-America Dairymen, lnc./Lebanon, Mo. (M,Sl

Imported from Switzerland. Shipper unknown. Reese Finer Foods/Chicago, Ill. (Distributor)

Fail to conform to standard of quality for canned cherries; more than 15 percent of blemished cherries. Fails to bear an accurate statement of the quantity;

ascorbic acid is not declared on label. Not in conformity with the Fair Packaging and

Labeling Act.

"; water has been added to lime juice to increase its bulk or weight and reduced its quality.

Multi-ingredient processed, hot pack, cream product sold as "sour cream"; culture aroma added; inconspicuous labeling.

Not in conformity with the Fair Packaging and Labeling Act.

PRODUCT, PLACE & DATE SEIZED MANUFACTURER (M), PACKER (P),SHIPPER (S), DEALER (D)

Dwarfies Daily Dozen—Thirteen Vitaminsw/Lemon Bioflavonoids Complex/St.

Joseph, Mo. 9/2/71

Vitamins—Dietary FoodDwarfies Corp./St. Joseph, Mo. (D) False and misleading labeling suggesting that lemon

bioflavonoids are nutrients with special dietaryproperties; lacked required information concerningpurported special dietary uses.

DRUGS/Human Use

Arseno-Phos injection/Detroit, Mich. Atlas Pharmaceutical Labs, Inc./Detroit, Not in conformity with good manufacturing practice.7 / 2 2 / 7 1 M i c h . ( M ) I n g r e d i e n t s s h i p p e d f r o m N . Y.

"Gynben" vaginal suppositories/St. Louis, Lee Way Motor Freight/St. Louis, Mo. (S) Held in a truck in which a toxic chemical reportedlyM o . 7 / 1 4 / 7 1 r u p t u r e d a n d s p i l l e d i t s c o n t e n t i n t r a n s i t .

C O S M E T I C

Brylcreem/Detroit, Mich, 8/26/71 Beecham Products/Brentford, England (M) Inconspicuous labeling.

HAZARDOUS SUBSTANCES

Class B Fireworks/near Trenton, Mo.6/30/71

near Princeton, Mo. 6/30/71

near Mercer, Mo. 6/30/71 (2 actions)near Tarkio, Mo. 7/16/71near Wayland, Mo. 7/1/71near Des Moines River Bridge, Clark

County, Mo. 7/1/71Claud, Ala. 7/2/71Wetumpka, Ala. 8/2/71near Jackson, Mo. 7/1/71

Ice-O-Magic, storable refrigerant forportable ice chests/Glen Burnie, Md.8/18/71

Travel-Ice refrigerant/New Orleans, La.8/26/71

Stand, approx. 3 miles N. of Trenton, Mo.(D)

Stand, nr. junct. 136 & 65, Princeton, Mo.(D)

Stand, 4 miles S. of Mercer, Mo. (D)Ted's Tobacco & Grocery, nr. Tarkio, Mo. (D)Kinkeade's, 1 mile S. of Wayland, Mo. (D)Tent, SE side of US 61/136, Clark County,

Mo. (D)K & R Grocery/Claud, Ala. (D)Grantham's Gulf Station/Wetumpka, Ala. (D)Kinder Fireworks/RED #2, Jackson, Mo. (D)Chase Chemical Corp./Jacksonville, Fla., and

Unipak, Inc./lndianapolis, Ind. (S)

Linco Products Co./Costa Mesa, Calif. (M.S)

Banned hazardous substances; lack consumer protection information required by the Fed. HazardousSubstances Act.

Lacks consumer protection information required bythe Fed. Hazardous Substances Act.

Label fails to bear common or chemical name ofsubstance or each component, principal hazard, precautionary measures, instructions for first aid treatment, and instructions for handling and storage.

U.S. POSTAL SERVICE actions taken in medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341)and/or the False Representation Statute (39 U.S.C. 3005) as reported by the AssistantPostmaster General—Inspection Service.

False Representation Orders Issued by Judicial Officer Under 39 U.S.C. 3005

September 2, 1971: False Representation Order issued againstThornwood Laboratories, 10 Burnside Ave., Congers, New York.Advertising and sale by mail of "Slenro Capsules" representedas enabling users to lose 10 pounds in one month.

September 9, 1971: False Representation Order issued against BruceRoberts Co., 89 Worth St., New York, New York. Solicitations oforders and sales through the mails of "Viran" tablets representedas a sexual rejuvenator.

Complaints Filed by the Law Department Under 39 U.S.C. 3005 (False Representation)

August 27, 1971: Easy Slim, Dept. 15-A26, Box 742, Encino, California.Firm advertised that the use of grapefruit juice, as prescribedin the diet plan, contributes to rapid weight loss by acting asa catalyst to help the body burn excess fat and body fluids.

September 17, 1971: Power Fashion Model Slims, 5th Floor, 3 West30th St., New York, New York, and Power Fashion Model Slims,Inc. Advertising and sale through the mails of "Power FashionModel Slim Capsules" guaranteed as enabling subscribers tolose 10 pounds in 10 days.

September 13, 1971: Wonder Belt, 1044 Northern Blvd., Roslyn, NewYork. Advertising and sale by mail of a "Wonder Belt" represented as enabling wearers to reduce and melt away excessfat from any particular part of their anatomy.

September 21, 1971: Neltor, Inc., and Grapefruit Diet Division, FortLauderdale, Florida. Firm advertised that newest Grapefruit"Super-C" diet enables subscribers to eat all they want whilelosing and retaining a substantial weight loss year after year.


notices of judgmentNOTICES OF JUDGMENT on Seizure Actions

FOOD/Poisonous and Deleterious Substances

Copra meal products, at Wilmington, 0. Dist. Calif.Charged 5-21-70: when shipped from the Philippines, the article containedan added poisonous and deleterious substance, namely, aflatoxin;402(a)(1). Consent decree ordered delivery to Baker Commodities, Inc.,Los Angeles, Calif., for export to original foreign supplier. (1)

C o t t o n s e e d m e a l , a t D r a p e r , D i s t . U t a h . . . ^ ^Charged 12-29-70: while held for sale, the article contained an addedpoisonous and deleterious substance, namely, aflatoxin; 402(a)(1). Defaultdecree ordered destruction. (2)

L e t t u c e , S i n g h ' s , a t D e t r o i t , E . D i s t . M i c h . . ^ .Charged 11-17-69: when shipped by Rala Singh Farms, Glendale, Ariz.,the article contained the pesticide chemical toxaphene in excess of theprescribed tolerance; 402(a)(2)(B). Default decree ordered destruction. (3)

Peanuts, shelled, at Milwaukee, E. Dist. Wis.Charged 2-8-71: while held by Jack Gronik Co., Milwaukee, Wis., a portion of the article contained the added poisonous and deleterious substance, aflatoxin, and all lots of the article contained insects, and wereheld under insanitary conditions in an insect-infested plant; 402(a)(1),402(a)(3), 402(a)(4). Consent decree ordered destruction of the portion ofthe article containing aflatoxin, and a separate consent decree orderedthe release of the remainder of the article to the dealer for reconditioning. (4)

Pepper, black, whole, at South San Francisco, N. Dist. Calif.Charged 3-25-71: while held by Fresco Food Products, Inc., South SanFrancisco, Calif., the article contained the poisonous and deleterious substance, Salmonella micro-organisms, and was held under insanitary conditions; 402(a)(1), 402(a)(4). Consent decree authorized release to thedealer for salvaging. (5)

Swordfish, at Gloucester. Dist. Mass.Charged 2-19-71: when imported into the United States from Norway, thearticle contained an added poisonous and deleterious substance, mercury;402(a)(1). Consent decree authorized release to Danland Seafood Corp.,New York, N.Y., for export to oiginal foreign supplier. (6)

Swordfish, 2 seizure actions at Wilmington, C. Dist. Calif.Charged 3-30-71: when caught in waters outside the territorial limits ofthe State of California, the article contained an added poisonous anddeleterious substance, mercury; 402(a)(1). Default decree ordered destruction. (7)

FOOD/Contamination, Spoilage, Insanitary Handling

Beans, black, at Dania, S. Dist. Fla.charged 10-22-70: whiie held by Steinfeldt Thompson Co., Inc., Dania,Fla., the article contained insect filth and moldy beans and was heldunder insanitary conditions; 402(a)(3), 402(a)(4). Consent decree ordereddestruction. (8)

Cornmeal, white, at Shreveport, W. Dist. La.Charged 2-10-71: while held by Salley Grocer Co., Inc., Shreveport, La.,the article contained rodent urine and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (9)

Cornmeal, white, at Shreveport, W. Dist. La.Charged 2-18-71: when shipped by The Quaker Oats Co., Dallas, Tex., thearticle contained rodent urine; 402(a)(3). Default decree ordered destruction. (10)

Donut mix, American Beauty, at Claremont, Dist. N.H.Charged 1-27-71: when shipped by Peavey Company Flour Mills, Buffalo,N.Y., the article contained insect filth and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruct ion. (11)

Flour, at Chicago, N. Dist. III.Charged 2-3-71: while held by Certified Grocers of Illinois, Inc., Chicago,III., the article contained rodent filth and had been held under insanitaryconditions; 402(a)(3), 402(a)(4). Consent decree authorized release todealer for salvaging. (12)

Flour and rice, at Corona, C. Dist. Calif.Charged 2-26-71: while held by Certified Grocers of California, Ltd..Corona, Calif., the articles contained rodent filth and had been heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decree orderedd e s t r u c t i o n . ( 1 3 )

Flour and sugar, at Franklin Park, N. Dist. III.Charged 2-17-71: while held by Central Grocers Cooperative, Inc.. Franklin Park, III., the article contained rodent filth and had been held underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to the dealer for salvaging. (14)

Nuts, mixed, at Des Moines, S. Dist. Iowa.Chargey 11-5-70: when shipped by Johnson Nut Co., Div. of Fairmont

Foods Co., Hopkins, Minn., the article contained insect fragments andhad been prepared and packed under Insanitary conditions; 402(a)(3),402(a)(4). Consent decree ordered destruction. (15)

Peas, pidgeon, dried, Dixie Lily, at Hialeah, S. Dist. Fla.Charged 12-11-70: while held by R. H. Hammond Co., Inc., Hialeah, Fla..who repacked the article, the article contained live insects and insectfilth; 402(a)(3). Default decree ordered destruction. (18)

Pecan pieces. Prairie State, at Honolulu, Dist. Hawaii.Charged 12-10-70: when shipped by John B. San Fllippo & Son, Inc.,Chicago, III., the article contained E. coll: 402(a)(3). Consent decreeauthorized release to shipper for salvaging. (17)

Potatoes, hash-brown, frozen, Flav-R-Pac, at Little Rock, E. Dist. Ark.Charged 1-11-71: when shipped by North Pacific Canners & Packers, Inc.,Portland, Greg., the article contained bacterial filth and was preparedand packed under insanitary conditions; 402(a)(3), 402(a)(4). Defaultdecree ordered destruction. (18)

Rice, at Phoenix, Dist. Ariz.Charged 2-16-71: while held by P. M. Foods, Inc., Phoenix, Ariz., thearticle contained rodent filth and was held under insanitary condiiions;402(a)(3), 402(a)(4). Default decree ordered destruction. (19)

Saimin noodles with instant soup base, at San Francisco, N. Dist. Calif.Charged 11-13-70: when shipped by Okahara Saimin Factory, Ltd., Honolulu, Hawaii, the article contained insect fragments and was preparedand packed under insanitary conditions; 402(a)(3X 402(a)(4). Default decreeordered des t ruc t ion . (20 )

Shrimp, breaded, frozen, at Jacksonville, M. Dist. Fla.Charged 1-11-71: when shipped by Sea Pak Division of W. R. Grace &Co., St. Simons Island, Ga., the article contained bacterial filth and hadbeen prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (21)

Shrimp, breaded, frozen, at Columbia, Dist. S.C.Charged 1-6-71: when shipped by Golden Shore Seafoods, Inc., Brunswick,Ga., the article contained a high bacterial count and was prepared andpacked under insanitary conditions; 402(a)(3), 402(a)(4). Consent decreeordered destruction. (22)

Shrimp pieces, brewed, frozen, Thunderbolt, at Milwaukee, E. Dist. Wis.Charged 3-3-71: when shipped by Sea Pak Division of W. R. Grace & Co.,St. Simons Island, Ga., the article contained bacterial filth and had beenprepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (23)

Tomatoes, canned, at Denver, Dist. Colo.Charged 3-9-71: while held for sale, the article contained a decomposedsubstance; 402(a)(3). Default decree ordered destruction. (24)

Yams, canned, at BIytheville, E. Dist. Ark.Charged 5-13-70: while held for sale, the article contained a decomposed substance; 402(a)(3), Consent decree authorized release to BIytheville Canning Co., BIytheville, Ark., for salvaging. (25)

FOOD/Economic and Labeling Violations

Applesauce, canned, Visscher Brothers, at Denver, Dist. Colo.Charged 3-9-71: when shipped by Lyndonville Canning Co., Lyndonville,N.Y., the article was in violation of the Fair Packaging and Labeling Act,in that the quantity of contents declaration was not in the bottom 30percent of the principal display panel and was expressed as "Net Contents 2 Lbs. 3 Oz." instead of "Net Wt. 35 Oz. (2 Lbs. 3 Oz.)"; and inthat the principal display panel had an area of between 25 and 100square inches and the net quantity of contents was stated in a typesize less than 3/16 inch high; 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i).Consent decree authorized release to shipper for relabeling. (28)

Corn, white, at Seattle, W. Dist. Wash.Charged 3-15-71: while held for sale, the article contained insect-damagedcorn, and insect filth; and, when imported into the United States, thearticle's label failed to bear the name and place of business of themanufacturer, packer, or distributor, an accurate statement of the quantity of contents, and the common or usual name of the article; 402(a)(3),403(e)(1). 403(e)(2), 403(i)(l). Consent decree authorized release toJensen-McLean Co., Inc., Seattle, Wash., for conversion to animal feed. (27)

SaJmon, pink, canned. Golden Shore, at Greenville, Dist. S.C.Charged 2-4-71: when shipped by Whitney-Fidalgo Seafoods, Inc., Seattle,Wash., coho salmon had been substituted wholly or in part for pinksalmon, and the name "pink salmon" was false and misleading as applied to a product that was not pink salmon; 402(b)(2). 403(a). Consentdecree authorized release to shipper for relabeling. (28)

VITAMINS/SPECIAL DIETARY FOODS

Lean vitamin-mineral capsules, at Oakland, N. Dist. Calif.Charged 8-3-70: while held by Ray Drug Co., Inc., Oakland, Calif., whopacked the article, the article's valuable constituents, vitamin B-12 and


calcium pantothenate had been In part omitted or abstracted, and thename Leen" and the label statement "For Reducing Diets" were falseand misleading in representing that the article had some unique property which would cause weight reduction; and the label statement "Theneed m human nutrition for calcium pantothenate has not been estab-

402(b)a). 403(a). Consent decreeordered the destruction of the article and the return of certain aduer-tising material and display boxes to the dealer. (29)

FOOD ADDITIVES

Castor bean meal, processed, Plainsman, at Swink, Dist. Colo.Charged 11-3-70: when shipped by Plains Cooperative Oil Mill, Inc., Plain-view, Tex., the article was a food additive which was unsafe, since therewas no regulation or exemption in effect for its intended use in fattening cattle; 402(a)(2)(C). Default decree ordered destruction. (30)

Rantsite crushed stone, at Hutchinson, Dist. Minn.Charged 12-22-70: when shipped by Carl Schmidt, Florence, Colo., thearticle was a food additive for which there was no regulation or exemption for its use and intended use for livestock and poultry; the article'slabeling contained false and misleading claims of the article's value asa source of supplemental minerals for livestock and poultry; and thelabel failed to bear the common or usual name of the article; 402(a)(2)(C),403(a)^ 403(0(1). Consent decree authorized release to Welch Sales,Hutchinson, Minn., for relabeling as a soil conditioner. (31)

ANIMAL FEED

All Ration rabbit pellets. Chick Grow mash, and 40% hog concentrate. Diamond"S," at Colorado Springs, Dist. Colo.Charged 11-20-70: while the articles were held by Simpson & Co., Colorado Springs, Colo., after manufacture from ingredients shipped in interstate commerce, the Diamond "S" All Ration rabbit pellets was ananimal feed containing a new animal drug and no approval of a NewAnimal Drug Application filed with respect to such animal feed was ineffect; all of the articles lacked labels bearing the established namesof each of their active ingredients; and the labeling of the Diamond '-S"Chick Grow mash which represented that such article contained procainepenicillin was false and misleading, since the article contained no procainepenicillin; 501(a)(6), 502(a), 502(e)(l)(A)i(ii). Default decree provided fordonation to a public agency for nonfood use. (32)

Super 700 animal feeds, Big A Crumbles, Hi-Energy Range Cube, and 3-ln-1Super Cube, at La Salle, Vona, and Colorado Springs, Dist. Colo.Charged 1-13-71; while held for sale after manufacture by John EwingCo., La Salle, Colo., from ingredients shipped in interstate commerce,the circumstances of the manufacture and packing of all of the articleslacked conformity with current good manufacturing practice— 501(a)(2)(B);the articles, Super 700 and Big A Crumbles, were animal feeds containing new animal drugs, namely, chlortetracycline and sulfamethazine, andthe article, Hi-Energy Range Cube, was an animal feed containing a newanimal drug, namely, neomycin, and no approvals of application filed withrespect to such animal feeds were in effect—501(a)(6); the label of thearticle, Super 700, bore false and misleading claims that the articlewas adequate and effective in producing healthier, faster growing animalsat lower cost and in reducing mortality—502(a); the label of the article,Hi-Energy Range Cube, bore false and misleading claims that the articlew a s a d e q u a t e a n d e f f e c t i v e t o p r o v i d e s p e c i a l b e n e fi t t o c o w a n d c a l f a tcalving time—502(a); the labels of the articles. Super 700 and Big ACrumbles, lacked the established name of the active ingredient, sulfamethazine—502(e)(l)(A)(ii); the labeling of all of the articles lacked adequate directions for use—502(f)(1); and the labeling of the article,3-ln-l Super Cube, lacked adequate warnings against use—502(f)(2). Cons e n t d e c r e e a u t h o r i z e d r e l e a s e t o t h e m a n u f a c t u r e r t o b e b r o u g h t i n t ocompliance with the law. (33)

DRUGS/Human Use

Estradiol valerate and estradiol valerate injection, at Buena Park, C. Dist. Calif.Charged 2-19-71: while held by Tera Pharmaceuticals, Inc., Buena Park,Calif., who manufactured the injection from a portion of the estradiolvalerate powder from Italy, estradiol isovalerate and free estradiol hadbeen substituted wholly or in part for estradiol valerate, and the repres e n t a t i o n i n t h e l a b e l i n g o f t h e a r t i c l e t h a t t h e e s t r a d i o l i n g r e d i e n t o fthe article consisted solely of estradiol valerate was false and misleading; 501(d)(2), 502(a). Default decree ordered destruction. (34)

Estrand Gens methyltestosterone tablets, at North Hollywood, C. Dist. Calif.Charged 3-10-71: when shipped by Richlyn Laboratories, Inc., Philadelphia, Pa., the article was deficient in methyltestosterone (approx. 19percent); 501(c). Default decree ordered destruction. (35)

Jim's tonic, at Rome, N. Dist. Ga.Charged 2-8-71: when shipped by Jim OIlis, Inc., Gallatin, Tenn., thec i r c u m s t a n c e s o f t h e a r t i c l e ' s m a n u f a c t u r e l a c k e d c o n f o r m i t y w i t h g o o dmanufacturing practice; its labeling contained false and misleadingclaims concerning the efficacy of the article in the treatment of arthritis;its labeling lacked adequate directions for use for arthritis, since adeq u a t e d i r e c t i o n s c o u l d n o t b e w r i t t e n f o r s u c h u s e ; a n d t h e a r t i c l e w a sa n e w d r u g w i t h o u t a n e f f e c t i v e a p p r o v e d N e w D r u g A p p l i c a t i o n ;

501(a)̂ (2̂ (B), 502(a), 502(f)(1), 505(a). Default decree ordered destruc-Ossonate Plus injectable, Ossonate Plus Capsulets, and Viro-Zyme injection,

2 seizure actions at Hato Rey, Dist. P.R.Charged 10-17-69 and 12-18-69: when shipped by Marcen Laboratories,Inc., New Rochelle, N.Y.^ the articles were new drugs without effectiveapproved New Drug Applications; 505(a). Default decrees ordered destruction. (37)

Pluronic F-68 flakes and powder, at Denver, Dist. Colo.Charged 4-2-71: while held by Bruce C. Paton, M.D., Denver, Colo., thelabeling of the flakes and powder lacked adequate directions for use,a n d t h e a r t i c l e s w e r e n o t e x e m p t f r o m s u c h r e q u i r e m e n t , s i n c e t h e ywere new drugs for which no approval of a New Drug Application was

claimed investigational exemption was effective; 501(c), 502(f)(1). Consent decree ordered destruction. (38)Prednisone tablets U.S.P., at Philadelphia, E. Dist. Penn.

I ^ ^ ^ r s h a l P h a r m a c a l C o r p . , S o u t hHackensack, N.J., the article s strength differed from and its quality fellstandards for content uniformity; 501(b). Default decree

ordered destruction. (39)

''""N*°Dilt'̂ c"a l̂if^®*^*®* injectable, at San Francisco,Charged 11-30-70: when shipped by Glogau & Co., Inc., Chicago, Ml., thearticle was a new drug without an effective approved New Drug Application; 505(a). Consent decree ordered destruction. (40)

Thyroxine in lodinated casein tablets, at Sioux City, N. Dist. Iowa.Charged 2-3-71: when shipped by Austra Chemical, Inc., from FountainValley, Calif., the article was a new drug without an effective New Drug

labeling lacked adequate directions for use; 505(a),502(f)(1). Default decree ordered destruction. (41)

MEDICAL DEVICES

Theramatic model A-6DT40 electronic instrument, at Rockford, N. Dist. III.Charged 7-28-70: when shipped in interstate commerce after manufactureby Dynapower Systems Corp., Los Angeles, Calif., the article failed tobear in its labeling adequate directions for use for the purposes intended, since such directions could not be written for use by laymen ofthe article for such purposes; and the article was not exempt as an Rxdevice from the requirement of adequate directions, since adequate information for its use could not be furnished under which practitionerscould use the article safely and for the purposes intended; 502(f)(1).Default decree ordered destruction. (42)

Zelgler facial exerciser, at Bethany, W. Dist. Okla.Charged 9-28-66: when shipped by Zeigler Electronics, Inc., Gardena,Calif., the labeling of the article contained false and misleading representations and suggestions that the article was adequate and effectiveas a treatment for fine lines, wrinkles, loose facial skin, and saggingfacial contours about the eyes, cheeks, and chin line; to tighten skin;improve tone and texture, firmness and strength of muscles; improvecirculation; build complexion; improve shape of facial contours of mouth,cheek, jowl, neck, eyebrow arch level, area between eyelid and eyebrow,and area over bridge of the nose: mitigate effects of aging on facialskin; and create more youthful contours; 502(a).Pursuant to stipulation by the Government and the claimant, ZeiglerElectronics, Inc., the case was removed for trial to the Southern Districtof California. Interrogatories were filed by the claimant and the Government and were answered. Thereafter, the claimant having consentedto the entry of a decree without admitting any issues of law or fact,and the court having adjudged that the article was misbranded, a decreewas entered which provided for the condemnation of the article and forits release to the Department of Health, Education, and Welfare for exhibit purposes. In addition, the decree enjoined the claimant from introducing and delivering for introduction into interstate commerce anyarticle designated as "Zeigler Facial Exerciser" or any similar articlewhich was accompanied by written, printed, or graphic matter whichrepresented and suggested that the article was adequate and effectivefor the purposes and conditions described above. (43)

PROPHYLACTICS

Prophylactics, rubber, at Philadelphia, E. Dist. Pa.Charged 7-2-70: while held by Nutex Corp. of America, Philadelphia, Pa.,after repacking by that firm, the article's quality was deficient and thelabel statement "Sold for Prevention of Disease Only"-' was false andmisleading because of the presence of holes in the article; 501(c), 502(a).Default decree ordered destruction. (44)

Prophylactics, rubber. Peacocks, at Milwaukee, E. Dist. Wis.Charged 4-19-71: when shipped by Dean Rubber Co., North Kansas City,Mo., the article's quality was deficient, since the article contained holes;501(c). Default decree ordered destruction. (45)

HAZARDOUS SUBSTANCES

Detergent, at Brooklyn, E. Dist. N.Y.Charged 3-8-71: when shipped by North American Chemical Corp., Pater-son, N.J., the article, labeled in part "Bohack No Phosphates ControlledSuds Detergent . . . Distributed by H. C. Bohack Company, Inc., Brooklyn, New York," was toxic, corrosive, and an irritant and lacked a number of the required conspicuous label statements; 2(p)(l)(B,C,E,G,j). Consent decree authorized release to the shipper for relabeling. (46)

NOTICES OF JUDGMENT on Cr iminal Act ions

Dixie Egg Co. of Georgia, and Meyer Klempf, president, Donalsonville, M.D i s t . G a .Charged on or about 9-14-70 by grand jury: when shipped, frozen eggsand frozen egg whites, labeled in part "humpty-dumpty Whole Eggs [or"Pasteurized Egg Whites"] Packed by Dixie Egg Co. Donalsonville,Georgia," contained the added poisonous and deleterious substance,viable Salmonella micro-organisms; and the frozen eggs and frozen eggwhites failed to conform to the prescribed standards of identity, sincethe articles contained viable Salmonella micro-organisms; 402(a)(1),403(g)(1). Guilty pleas; fines. (47)

Piantedosi Baking Co., Inc., and John Piantedosi, Everett, Dist. Mass.Charged 9-23-70: flour was held in a building accessible to rodents andinsects and was contaminated with rodent and insect filth, and rollswere shipped which contained rodent and insect filth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Guiltypleas; fines. (48)


D R U G S

Dow Corning Corp., and A. W. Rdodes, director of Medical Products Division,Hemlock, E. Dist. Mich.Charged 8-16-67 by grand jury: when shipped, Dow Corning MedicalFluid 360 was a new drug without an effective approved New DrugApplication—505(a); and the article's labeling lacked adequate directionsfor use and lacked adequate warnings against unsafe use—502(f)(1),502(f)(2).

The defendants filed a motion for discovery and inspection. Therea f t e r t h e d e f e n d a n t s m o v e d t o d i s m i s s t h e a c t i o n . T h e c o u r t r e n d e r e dthe following ruling:

"Defendants are charged in a sixteen count indictment with violatingthe Federal Food, Drug, and Cosmetic Act, Title 21, U.S.C., Sections310-392, relating to eight shipments of a product designated as 'DowCorning Medical Fluid 360.' The odd numbered counts charge unlawfulshipments of a 'new drug' without first complying with certain statutoryrequirements. The even numbered counts charge shipments of a 'drug'which was 'misbranded,' as defined by Title 21, U.S.C., Section 352(f),relating to directions for use and warning on labels.

" T h e c a s e i s b e f o r e t h e C o u r t o n d e f e n d a n t s ' m o t i o n t o d i s m i s s t h eindictment—Rule 12, Federal Rules of Criminal Procedure, 18 U.S.C.A.Before considering the defendants' numerous grounds in support of themotion, it must be noted that Rule 12(b)(1) provides that 'any defenseor objection which is capable of determination without trial of the genera l i s sue may be ra i sed be fo re t r i a l by mo t i on . '

De fendan t s con tend :(1) that as to all counts, the product shipped was not a 'drug' or

a 'new drug' as defined by the Act;(2) that as to counts 1, 3, 5, 7, 9, 11, and 13, there were no ship

ments of 'new drugs,' as defined by the Act;(3) that as to counts 2, 4, 6, 8, 10, 12, and 14; no shipments of mis-

branded drugs were made within the meaning of the Act."These contentions go to the very foundation of this prosecution. The

Government has charged that the silicone fluid is a 'drug,' and further,that it is a 'new drug' within the meaning of the Act. Defendants claimthat the classification of this product, for the purposes of the Act, is aquestion of law and that as a matter of law, their contention as to theproper characterization is the correct one. Whether the classification isa question of fact, law, or both, the Court cannot make lhat determination until the Court hears the evidence the parties will produce at trial.United States v. J. R. Watkins Co., 16 P.R.D. 229 (Minn. 1954). UniversalMilk Bottle Service v. United States, 188 F. 2d 959 (Sixth Cir., 1951).Cf. United States v. Fargas, 267 F. Supp. 452 (S.D. N.Y. 1967).

D e f e n d a n t s f u r t h e r c o n t e n d :(4) that as to counts 1 to 14, inclusive, these counts disclose thatfull and complete compliance was made with the Federal Regu

lations in effect in 1964 pertaining to the shipping of drugs ininterstate commerce, to-wit: 21 CFR 130(f)(1);

( 5 ) t h a t c o u n t 1 5 c o n t a i n s a G o v e r n m e n t a d m i s s i o n t h a t t h e p r o d u c tbore a label setting forth that the product was not intended foruse as a drug;

(6) that count 16 contains a Government admission that the substance bore a label setting forth that the product was not intended for use as a drug, nor does that count allege acts suffic i e n t t o c o n s t i t u t e a v i o l a t i o n o f t h e A c t .

"Again, these are contentions which go to the general issue of thecase. They are properly matters of evidence which the defendants willprobably use to prove that they are not guilty. United States v. J. L.Hopkins & Co., 228 F. 173 (S.D. N.Y. 1912).

T h e i n d i v i d u a l d e f e n d a n t s c o n t e n d :(7) that they committed no wrongful acts, either individually or as

officers, servants and agents of Dow Corning Corporation, whichc o n s t i t u t e a v i o l a t i o n o f t h e A c t .

"The defendants claim that the shipments named in the indictmentwere made without any actual knowledge on their part. Accordingly, theycontend that the indictment is faulty in that it does not charge anyintent to commit an unlawful act on their part. The Federal Food, Drug,and Cosmetic Act does not require either intent or knowledge for amisdemeanor violation. United States v. WIesenfeld Warehouse, 376 U.S.86, 11 L. Ed. 2d 536, 84 S. Ct. 559 (1964). Palmer v. United States,340 F. 2d 48 (Fifth Cir., 1964).

T h e d e f e n d a n t s f u r t h e r c o n t e n d :(8) that those sections of the Act forming the basis of this prose

cution, and in particular, the odd numbered counts, are vague,indefinite and uncertain and accordingly, deprive them of thoserights guaranteed to them under the Fifth and Sixth Amendmentst o t h e C o n s t i t u t i o n o f t h e U n i t e d S t a t e s .

"As to properly informing the defendants of what they are charged,the counts are not unconstitutional. United States v. Calise, 217 F. Supp.705 (S.D. N.Y. 1962). The thrust of this argument, as to both the definition of 'drug' and 'new drug' is that under the statute, they have theburden of determining whether the silicone fluid is a drug, device,cosmetic, or new drug as these terms are defined in the Act. They arguethat if these distinctions can be made clearly, distinctly, definitely, andwithout hazard, then the statute is sound; if not, then the statute is unconstitutionally vague. However, as Mr. Justice Holmes stated in UnitedStates V. Wurzbadi, 280 U.S. 396-399, 74 L Ed. 508, 50 S. Ct. 167;

' W h e n e v e r t h e l a w d r a w s a l i n e t h e r e w i l l b e c a s e s v e r y n e a re a c h o t h e r o n o p p o s i t e s i d e s . T h e p r e c i s e c o u r s e o f t h e l i n e m a ybe unce r t a i n , bu t no one can come nea r i t w i t hou t know ing he doesso , i f he t h i nks , and i f he does so i t i s f am i l i a r t o t he c r im ina l l awto make him take the risk. Nash v. United States, 299 U.S. 373, 57L. Ed. 1232, 33 S. Ct. 780.'

"The fact that arguments can be made to support a contention thatthis silicone fluid belongs on a certain side of line that Congress hasdrawn does not make the statute unconstitutional. Furthermore, a statutecontaining definitions on which there are differences of opinion anddegrees of judgment does not make it unconstitutional. Berger v. UnitedStates, 200 F. 2d 818 (Eighth Cir., 1952). Dean Rubber ManufacturingCo., V. United States, 356 F. 2d 161 (_Eighth dr., 1966). See also UnitedStates V. Sweet Valley Wine Co., 208 F. 85 (Sixth Cir. 1913).

"The practical difference between characterizing something as a drugor a device is that as to a new drug, the Secretary of Health, Educat i o n a n d W e l f a r e m u s t a p p r o v e a n a p p l i c a t i o n t o s h i p t h e d r u g m i n t e rstate commerce before the drug can be so shipped. Prior to marketinga n e w d r u g c o m m e r c i a l l y, t h e a p p l i c a n t m u s t s h o w t h a t t h e p r o d u c t i ss a f e a n d e f f e c t i v e f o r i t s i n t e n d e d u s e . T h e r e i s n o s u c h p r e - m a r k e tc l e a r a n c e r e q u i r e m e n t f o r d e v i c e s . T h e c h o i c e o f t h e p r o p e r c l a s s i fi c a

tion is not as difficult as defendants make it out to be. With the guidance of the avowed Congressional policy of protecting the public health,when an item is capable of coming within two definitions, there is reallyonly one answer, namely, that which affords the public the greatest protection. AMP, Inc. V. Gardner, 275 F. Supp. 410 (S.D. N.Y., 1967), affirmed389 F. 2d 825 (Second Cir. 1968). The statute is not void for vagueness.

The defendant finally contend:(9) that Congress has unlawfully delegated its power.

"This argument is not sound. It has long been settled that the Actitself is a constitutional exercise of the commerce power. McDermott v.Wisconsin, 228 U.S. 115, 33 S. Ct. 431, 57 L. Ed. 754 (1913). UnitedStates V. Walsh, 331 U.S. 437-439, 67 S. Ct. 1283, 91 L. Ed. 1585 (1947).'The true distinction ... is between the delegation of the power tomake the law, which necessarily involves a discretion as to what itshall be, and conferring an authority or discretion as to its execution,to be exercised under and in pursuance of the law. The first cannot bedone; to the latter no valid objection can be made.' Annot. 70 L. Ed.474, a t page 485.

"It is not a delegation of legislative power for Congress to allow administrators to make rules pertaining to reasonable variations, tolerances and exemptions. United States v. Shreveport Grain & Elevator Co.,287 U.S. 77-85, 53 S. Ct. 77 L. Ed. 175 (1932). Nor is it an unconstitutional delegation of power for Congress to let boards of experts determine whether a product is inferior in purity, quality, fitness for consumption. Buttfield V. Stranahan, 192 U.S. 470, 24 S. Ct. 349, 48 L. Ed.525 (1904). The use of experts and their judgments in the administration of the Federal Food, Drug, and Cosmetic Act does not make theA c t u n c o n s t i t u t i o n a l .

"Therefore, for the above-mentioned reasons, the motion to dismissthe indictment is denied. An appropriate order may be submitted."

Thereafter the individual pleaded nolo contendere to counts 1 and 2,and was fined $1,000. The corporation pleaded nolo contendere to counts1, 2, 3, 4, 13, 14, 15 and 16 and was fined $5,000. (49)

NOTICE OF JUDGMENT on Injunction Action

Better Foods Foundation Cooperative Association, a corporation, and John C.Eshleman, president, Reid, Dist. Md.Charged 9-30-68 in complaint for injunction: that the defendants wereengaged in manufacturing, processing, packing, and holding flour, buckwheat and pancake mixes, and cornmeal. were Introducing such foodsinto interstate commerce, and that such foods contained insect filth andwere prepared, packed, and held under insanitary conditions; 402(a)(3),402(a)(4).

Thereafter, pursuant to stipulation, the defendants agreed to ceaseo p e r a t i o n s a n d t o d e c h a r a c t e r i z e t h e f o o d o n h a n d f o r u s e a s a n i m a lfeed. Subsequently, a consent decree of injunction was entered whichenjoined the defendants against the violations complained of and whichrequired the defendants, before making any further shipments of suchfood in interstate commerce, to clean and render their plant suitablefor use in preparing foods for human consumption. (50)

N o t i c e s o f J u d g m e n t a r e g i v e n p u r s u a n t t o s e c t i o n 7 0 5 o f t h eFederal Food, Drug, and Cosmetics Act and section 13 of the FederalH a z a r d o u s S u b s t a n c e s A c t . N o t i c e s o f J u d g m e n t r e p o r t c a s e s i nv o l v i n g s e i z u r e p r o c e e d i n g s , c r i m i n a l p r o c e e d i n g s , a n d i n j u n c t i o np r o c e e d i n g s . S e i z u r e p r o c e e d i n g s a r e c i v i l a c t i o n s t a k e n a g a i n s tgoods alleged to be in violation, and criminal and injunction proceedings a re aga ins t fi rms o r ind iv idua ls charged to be respons ib le fo rv io la t ions . The cases genera l l y invo lve foods , d rugs , dev ices , cosm e t i c s , o r h a z a r d o u s s u b s t a n c e s w h i c h w e r e a l l e g e d t o b e a d u l t e r a t e do r m i s b r a n d e d o r o t h e r w i s e v i o l a t i v e o f t h e l a w w h e n i n t r o d u c e di n t o a n d w h i l e i n i n t e r s t a t e c o m m e r c e , o r w h i l e h e l d f o r s a l e a f t e rs h i p m e n t i n i n t e r s t a t e c o m m e r c e .

N o t i c e s o f J u d g m e n t a r e p r e p a r e d b y F o o d , D r u g , a n d E n v i r o nm e n t a l H e a l t h D i v i s i o n , O f fi c e o f t h e G e n e r a l C o u n s e l , D H E W .

P u b l i s h e d b y d i r e c t i o n o f t h e S e c r e t a r y o f H e a l t h , E d u c a t i o n , a n dW e l f a r e .

Charles C. Edwards, M.D., Commissioner of Food and DrugsWashington, D.C., November 1, 1971

40 / November 1971 / FDA Papers ☆U . S . G O V E R N M E N T P R I N T I N G O F F I C E : 1 9 7 2 - 4 8 2 - 0 8 3 / 1 0

Uncle Sam>^ntsy»u to Know

A new organization has been formed to make it easier for the consumer to iearnwhat the Federal Government knows about family economics, safety and health,medicines, food and nourishment, clothing and fabrics, appliances, automobiles,housing, landscaping, gardening, pest control, and a number of other subjects inwhich today's consumer has a stake.The Consumer Product information Coordinating Center has compiled a listof 192 publications published by 15 Federal Government agencies that containmany kinds of information useful to the householder. These publications may bepurchased at moderate cost. Many are free.For a free copy of the Consumer Product Information index of Selected FederalPublications on How to Buy, Use, and Take Care of Consumer Products, sendyour request to: Consumer Product Information, Washington, D.C. 20407. Bulksupplies of the index will be made available free to organizations for distributiont o t h e i r m e m b e r s .

UNITED STATESG o v e r n m e n t P r i n t i n g O f fi c e

D I V I S I O N O F P U B L I C D O C U M E N T S

WASHINGTON, D. C. 20402

P O S T A G E A N D F E E S P A I D

O F F I C I A L B U S I N E S S u . s . g o v e r n m e n t p r i n t i n g o f fi c e

COMMITTEE OFFICERS NAMED BradleyAllynn McMain, practicing communityp h a r m a c i s t , H o u s t o n , Te x a s , a n d am e m b e r o f t h e Te x a s P h a r m a c e u t i c a l A ssociation's Board of Directors, has beennamed Chairman of the Local HospitalityC o m m i t t e e f o r t h e 1 1 9 t h A m e r i c a nP h a r m a c e u t i c a l A s s o c i a t i o n a n n u a l m e e t

i n g t o b e h e l d A p r i l 2 2 - 2 8 , 1 9 7 2 , a tH o u s t o n .

The announcement made by APhAPresident Lloyd M. Parks also includednotice of the appointment of William J.Edwards, a practicing community pharmacist, Galveston, as secretary of theLocal Hospital i ty Committee.

T h e A P h A m e e t i n g w i l l b e h e l d i nw h a t h a s b e e n d e s c r i b e d a s " t h e w o r l d ' slargest and most unique entertainmentcomplex"—the Astrodomain. Supplemental hotels for meetings and sleepingrooms will include the nearby ShamrockH i l t o n a n d n e w H o u s t o n M a r r i o t t M o t o rH o t e l .

A n n o u n c e m e n t s

FDA POSTER AVAILABLE An employee-motivational poster, "Did You Really WashYour Hands," is now available to food industry management for use in promotingsanitation programs. The poster complements FDA's taped color-slide show, "CleanHands" (FDA Papers, March 1971). The use of this poster will remind employeesto keep their hands clean and encourage them to produce clean, safe food products.

Copies of the 15" x 20", two-color poster are available for 10 cents each. Toobtain copies, write to the Superintendent of Documents, U. S. Government PrintingOffice, Washington, D. C. 20402. Order by stock number 1712-0132.

( F D A ) 7 2 - 1 0 1 2